Deep Brain Stimulation Systems
Study Participants
Centers
The following deep brain stimulation tables and graphs were generated based on data collected between July 2009 and the report cut-off date of October 31, 2017. Thirty-eight centers, including sites in North America, Europe and South America, have enrolled and contributed patient data to the deep brain stimulation section of the report.
Patients
Of the 2,459 deep brain stimulation patients enrolled, 66.1% were implanted for the treatment of Parkinson’s Disease, 21.6% were implanted for the treatment of Essential Tremor, 8.2% were implanted for the treatment of Dystonia, 0.8% were implanted for the treatment of Obsessive Compulsive Disorder, 0.5% were implanted for the treatment of Epilepsy, 2.4% were implanted for the treatment of some other indication, and 0.5% were implanted for indications that were not specified in the database at the time of data cut-off.
As outlined in the PSR protocol, enrollment may be limited when the number of patients enrolled are sufficient to characterize product performance. As such an enrollment guide was implemented in the Fall of 2016, limiting future enrollment of Parkinson’s disease patients. The enrollment guide was implemented using a staged approach across all sites. Therapy-naïve patients in other indications (e.g., essential tremor, dystonia) continue to be enrolled to generate evidence for those indications.
Primary DBS Treatment IndicationsPrimary DBS Treatment Indications
Primary Treatment Indicationa |
Total Enrolled Patients (Percent) |
|---|---|
| Parkinson's disease | 1,626 (66.1%) |
| Essential Tremor | 530 (21.6%) |
| Dystonia | 201 (8.2%) |
| OCD | 20 (0.8%) |
| Epilepsy | 12 (0.5%) |
| Other | 58 (2.4%) |
| Not specified | 12 (0.5%) |
Total Subjects |
2,459 |
a Refer to product labeling for approved indications.
Event Summary
There were 205 product performance events reported between July 2009 and October 31, 2017, in patients with deep brain stimulation systems. These events represent 17.9% of the total reported events (205/1,166). These events occurred in 126 of the 2,459 total patients (5.1%) enrolled and are presented graphically within this report (e.g. events per patient years as well as survival curves).
In addition, there were 957 non-product performance events that were collected to understand patient experience (clinical signs and symptoms) with the deep brain stimulation systems. There were also 128 deaths reported for patients with deep brain stimulation systems. None of these deaths were reported as a direct result of a product performance event. All deaths are adjudicated for relatedness by a clinical events committee (CEC) comprised of independent physicians who review events for seriousness and relatedness.
Deep Brain Stimulation System Product Performance Events |
||||
| Eventa | Number of Product Performance Events |
Events per 100 Patient Years |
Number of Patients with Eventb |
Percent of Patients with Event (N=2,459) |
|---|---|---|---|---|
| High impedance | 94 |
1.92 |
53 |
2.2% |
| Lead migration/dislodgement | 24 |
0.49 |
18 |
0.7% |
| Device malfunction | 16 |
0.33 |
10 |
0.4% |
| Lead fracture | 14 |
0.29 |
14 |
0.6% |
| Medical device complicationc | 11 |
0.22 |
9 |
0.4% |
| Extension migration | 9 |
0.18 |
6 |
0.2% |
| Low impedance | 7 |
0.14 |
5 |
0.2% |
| Impedance increased | 6 |
0.12 |
2 |
0.1% |
| Extension fracture | 5 |
0.10 |
4 |
0.2% |
| Neurostimulator unable to recharged | 5 |
0.10 |
5 |
0.2% |
| Device breakagee | 4 |
0.08 |
4 |
0.2% |
| Premature battery depletion | 3 |
0.06 |
3 |
0.1% |
| Battery recharge issue | 2 |
0.04 |
2 |
0.08% |
| Device connection issue | 2 |
0.04 |
1 |
0.04% |
| Antenna cable breakage | 1 |
0.02 |
1 |
0.04% |
| Device migrationf | 1 |
0.02 |
1 |
0.04% |
| Electromagnetic interference | 1 |
0.02 |
1 |
0.04% |
| Totals | 205 |
4.18 |
126 |
5.12% |
a Medical Dictionary for Regulatory Activities (MedDRA) Lower-Level Term or Medtronic's coding system term for events that do not exist in the MedDRA dictionary.
b The total number of patients may not represent the sum of all rows, as a patient may have experienced more than one type of event.
c Includes 2 events for extension cable loop, 2 events for extension twisting, 1 event reported as
lead open circuit, 1 antenna heating while recharging, 1 suspicion of heating of the antenna while
recharging, 1 undesirable interaction with external electronic device, 1 short circuit, 1 open circuit,
and 1 issue with controller not communicating.
d There were 360 patients that used rechargeable neurostimulators for DBS in the registry. A total of 1.39% (5/360) of patients with a rechargeable neurostimulator experienced a neurostimulator unable to recharge event.
e Related to the external recharger
f Related to the adaptor
A total of 79 (38.5%) of the 205 product performance events were related to the lead, 36 (17.6%) were related to the extension, 31 (15.1%) were related to the neurostimulator, 26 (12.7%) were related to "multiple etiologies", which includes events where at least one device and one non-device etiology was indicated, 16 (7.8%) were related to external device components, 9 (4.4%) were related to surgery/anesthesia, 4 (2.0%) were related to the recharging process, 3 (1.5%) were related to programming/stimulation, and 1 (0.4%) was related to incisional site/device tract.
Relatedness is reported by the physician. In cases where the CEC has adjudicated relatedness differently from the site, the CEC adjudication is used in this report for analysis purposes. However, both the site's reporting and the CEC's adjudication remain in the database.
Product Performance Events by Relatednessa
a Each event could have more than one etiology.
Events not-related to a product-performance issue are characterized below. Due to the differences in event collection between the ISPR and PSR protocols, events per patient years and other rates are not calculated for non-product performance events.
Events are categorized by an event group term as noted in bold in the table below.
Deep Brain Stimulation System Non-Product Performance Events (including adverse eventsa and device events, excluding deaths and normal battery depletions) |
|
Eventsb |
Number of Non-Product Performance Events |
|---|---|
| Movement disorders (including parkinsonism) | 199 |
| Tremor | 82 |
| Dyskinesia | 47 |
| Dystonia | 27 |
| Freezing phenomenon | 11 |
| Parkinson's disease | 9 |
| Bradykinesia | 7 |
| Otherc | 16 |
| Neurological disorders Not Elsewhere Classified (NEC) | 133 |
| Dysarthria | 37 |
| Speech disorder | 31 |
| Paraesthesia | 26 |
| Balance disorder | 23 |
| Sensory disturbance | 7 |
| Otherc | 9 |
| Infections - pathogen unspecified | 100 |
| Medical device site infection | 77 |
| Wound infection | 12 |
| Otherc | 11 |
| Complications associated with device | 54 |
| Medical device site pain | 15 |
| Medical device site erosion | 13 |
| Medical device site inflammation | 6 |
| Otherc | 20 |
| Depressed mood disorders and disturbances | 52 |
| Depressiond | 51 |
| Otherc | 1 |
| General system disorders NEC | 44 |
| Gait disturbance | 31 |
| Pain | 5 |
| Otherc | 8 |
| Device issues | 43 |
| Neurostimulator migration | 25 |
| Otherc | 18 |
| Procedural related injuries and complications NEC | 33 |
| Wound dehiscence | 17 |
| Otherc | 16 |
| Injuries NEC | 26 |
| Fall | 9 |
| Subdural haematoma | 7 |
| Otherc | 10 |
| Anxiety disorders and symptoms | 22 |
| Anxiety | 17 |
| Otherc | 5 |
| Central nervous system vascular disorders | 22 |
| Cerebral haematoma | 8 |
| Otherc | 14 |
| Mood disorders and disturbances NEC | 19 |
| Apathy | 8 |
| Affect lability | 6 |
| Otherc | 5 |
| Deliria (including confusion) | 14 |
| Confusional state | 10 |
| Otherc | 4 |
| Psychiatric and behavioural symptoms NEC | 14 |
| Abnormal behaviour | 14 |
| Musculoskeletal and connective tissue disorders NEC | 12 |
| Otherc | 12 |
| Physical examination and organ system status topics | 12 |
| Weight increased | 12 |
| Bacterial infectious disorders | 11 |
| Staphylococcal infection | 8 |
| Otherc | 3 |
| Seizures (including subtypes) | 11 |
| Seizure | 5 |
| Otherc | 6 |
| Mental impairment disorders | 10 |
| Cognitive disorder | 6 |
| Otherc | 4 |
| Psychiatric disorders NEC | 10 |
| Mental disorder | 6 |
| Otherc | 4 |
| Disturbances in thinking and perception | 9 |
| Hallucination | 9 |
| Therapeutic and nontherapeutic effects | 9 |
| Otherc | 9 |
| Muscle disorders | 8 |
| Otherc | 5 |
| Suicidal and self-injurious behaviours NEC | 8 |
| Suicidal ideation | 5 |
| Administration site reactions | 7 |
| Otherc | 7 |
| Medication errors and other product use errors and issues | 7 |
| Otherc | 7 |
| Gastrointestinal signs and symptoms | 5 |
| Otherc | 5 |
| Headaches | 5 |
| Headache / Migrainee | 5 |
| Otherc | 58 |
Total |
957 |
aAdverse events associated with product performance events are not included in this table.
b Medical Dictionary for Regulatory Activities (MedDRA) or Medtronic’s own coding system terms for events that do not exist in the MedDRA dictionary.
c Composed of event codes with fewer than five events each.
d Includes depression (n=45), depression suicidal (n=4), and depressed mood (n=2).
e Includes headache (n=3) and migraine (n=2).
There were 128 deaths reported for patients with deep brain stimulation systems. None of these deaths were reported as a direct result of a product performance event. A total of 105 (82.0%) deaths occurred in patients receiving therapy for Parkinson’s disease, 19 (14.8%) for Essential Tremor, and four (3.1%) for Dystonia.
Number of Reports of Death by Primary Indication |
|
Primary Indicationa |
N (%) of deaths |
|---|---|
| Parkinson's disease | 105 (82.0%) |
| Essential Tremor | 19 (14.8%) |
| Dystonia | 4 (3.1%) |
Total |
128 |
a Refer to product labeling for approved indications
Neurostimulators
From July 2009 to the report cut-off date of October 31, 2017, 3,150 deep brain neurostimulators were followed in the registry. The difference between the total number of patients (N=2,459) versus neurostimulators is due to the fact that some patients have more than one neurostimulator implanted or were subsequently re-implanted. The aggregate prospective follow-up time for all neurostimulators was 62,527 months (5,211 years). The table below provides the number and percentage of neurostimulators by model.
Neurostimulators by Model | |
|---|---|
Model | Number of Neurostimulators (%) |
| Activa PC (37601) | 1,865 (59.2%) |
| Activa SC (37602/37603) | 814 (25.8%) |
| Activa RC (37612) | 364 (11.6%) |
| Other/Unspecified a | 28 (0.9%) |
| Neurostimulators No Longer Manufactured | |
| Soletra (7426) | 67 (2.1%) |
| Kinetra (7428) | 12 (0.4%) |
Total | 3,150 (100%) |
a Other includes Activa PC+S (n=10) and non-Activa systems used for DBS (n=18).
Neurostimulator Events Neurostimulator Events
Of the total of 205 product performance events, there were 34 product performance-related events with an underlying reported etiology related to deep brain neurostimulator function.
- Of these, 31 events had a neurostimulator etiology (13.7%), and 3 had both a neurostimulator and other etiology (including device and non-device etiologies).
- All 34 of these events were the initial product performance event that affected neurostimulator survival estimates.
For neurostimulators in the registry, the current return rate to Medtronic Returned Product Analysis (RPA) is 49/733 (6.7%). The proportion was based upon the number of registry neurostimulators received by RPA, divided by the total number of explanted devices plus the total number of deep brain stimulation devices in patients who have expired.
- Two of the 34 product performance-related events were confirmed by Medtronic RPA as premature battery depletion.
- The remaining 32 deep brain neurostimulators with performance-related events were not returned to Medtronic RPA but were assigned as device-related by the physician as high impedance (n=15), device malfunction (n=7), medical device complication (n=3), impedance increased (n=2), device connection issue (n=1), electromagnetic interference (n=1), low impedance (n=1) extension migration (n=1) and premature battery depletion (n=1).
For the purposes of survival analysis, a device’s follow-up time is cut-off for one of three reasons: 1) the occurrence of a product performance-related event; 2) the occurrence of a censoring event; or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off. For neurostimulators:
- 34 had follow-up time cut-off due to a product performance-related event.
- 1,258 were censored in the survival analysis for the following reasons: patient expired, neurostimulator explanted, patient discontinued, therapy suspended, or site discontinued participation in the registry.
- 1,858 were free from product performance-related events and censoring events, were censored at the last follow-up visit prior to the report cut-off.
Neurostimulator SurvivalNeurostimulator Survival
The figures and tables below represent neurostimulator survival and 95% confidence intervals where at least 20 neurostimulators contributed to each 3-month interval.
Model 37601 Activa PC: Survival from Neurostimulator Events
Data are shown if there are at least 20 devices in each 3-month interval.
Deep Brain Neurostimulator Characteristics |
|
|---|---|
| Model Name | Activa PC |
| FDA Approval Date | Apr 2009 |
| Neurostimulators Enrolled | 1,865 |
| Neurostimulators Currently Active in Study | 1,169 |
| Device Events | 21 |
| Cumulative Months of Follow-up | 37,204 |
Model Activa PC: Event Summary Table |
|
|---|---|
Neurostimulator Event |
Total |
| High impedance a | 8 |
| Device malfunction | 4 |
Impedance increased b | 2 |
Medical device complication c | 2 |
| Premature battery depletion | 2 |
| Device connection issue | 1 |
| Electromagnetic interference | 1 |
| Low impedance | 1 |
| Total Neurostimulator Events | 21 |
a Reported as high impedance attributed to neurostimulator, leads, extensions.
b Reported as increased impedance attributed to the neurostimulator and extension.
c Reported as undesirable interaction with external electronic device and open circuit.
| Time Interval | Survival (95% Confidence Interval) |
Sample Size |
|---|---|---|
| 1 yr | 99.2% (98.7%, 99.6%) |
1,197 |
| 2 yrs | 98.8% (98.1%, 99.3%) |
647 |
| 3 yrs | 98.8% (98.1%, 99.3%) |
300 |
| 4 yrs | 98.4% (96.8%, 99.2%) |
107 |
| 5 yrs | 98.4% (96.8%, 99.2%) |
34 |
Model 37601 Activa PC: Specifications
| Height | 2.6 in (65 mm) |  |
| Width | 1.9 in (49 mm) | |
| Thickness | 0.6 in (15 mm) | |
| Volume | 39 cc | |
| Battery type | Non-Rechargeable | |
| Expected Battery life | Depends on settings and use | |
| Maximum Electrodes | 8 | |
| Amplitude | 0 - 10.5 V (voltage mode) 0 - 25.5 mA (current mode) | |
| Rate | 2 - 250 Hz (voltage mode) 30 - 250 Hz (current mode) | |
| Pulse Width | 60 - 450 μsec | |
| Groups | 4 | |
| Programs | 16 (up to 4 per group) | |
| Implant Depth | ≤ 4 cm |
Models 37602 & 37603 Activa SC: Survival from Neurostimulator Events
Data are shown if there are at least 20 devices in each 3-month interval.
Deep Brain Neurostimulator Characteristics |
|
|---|---|
| Model Name | Activa SC |
| FDA Approval Date | Jan 2011 |
| Neurostimulators Enrolled | 814 |
| Neurostimulators Currently Active in Study | 426 |
| Device Events | 6 |
| Cumulative Months of Follow-up | 15,817 |
Model Activa SC: Event Summary Table |
|
|---|---|
Neurostimulator Event |
Total |
| High impedancea | 3 |
| Device malfunction | 1 |
| Medical device complicationb | 1 |
| Premature battery depletion | 1 |
| Total Neurostimulator Events | 6 |
a Reported as high impedance attributed to neurostimulator, leads and extensions.
b Reported as short circuit.
| Time Interval | Survival (95% Confidence Interval) |
Sample Size |
|---|---|---|
| 1 yr | 99.3% (98.2%, 99.7%) |
507 |
| 2 yrs | 99.0% (97.9%, 99.6%) |
287 |
| 3 yrs | 99.0% (97.9%, 99.6%) |
118 |
| 4 yrs | 99.0% (97.9%, 99.6%) |
46 |
| at 54 mo | 99.0% (97.9%, 99.6%) |
29 |
Models 37602 & 37603 Activa SC: Specifications
| Height | 2.2 in (55 mm) |  |
| Width | 2.4 in (60 mm) | |
| Thickness | 0.4 in (11 mm) | |
| Volume | 28 cc (Model 37602) 27 cc (Model 37603) | |
| Battery type | Non-Rechargeable | |
| Expected Battery life | Depends on settings and use | |
| Maximum Electrodes | 4 | |
| Amplitude | 0 - 10.5 V (voltage mode) 0 - 25.5 mA (current mode) | |
| Rate | 2 - 250 Hz (voltage mode) 30 - 250 Hz (current mode) | |
| Pulse Width | 60 - 450 μsec | |
| Groups | 4 | |
| Programs | 8 (up to 2 per group) | |
| Implant Depth | ≤ 4 cm |
Model 37612 Activa RC: Survival from Neurostimulator Events
Data are shown if there are at least 20 devices in each 3-month interval.
Deep Brain Neurostimulator Characteristics |
|
|---|---|
| Model Name | Activa RC |
| FDA Approval Date | Mar 2009 |
| Neurostimulators Enrolled | 364 |
| Neurostimulators Currently Active in Study | 255 |
| Device Events | 5 |
| Cumulative Months of Follow-up | 7,249 |
Model Activa RC: Event Summary Table |
|
|---|---|
Neurostimulator Event |
Total |
| High impedancea | 3 |
| Device malfunction | 1 |
| Extension migration | 1 |
| Total Neurostimulator Events | 5 |
a Reported as high impedance attributed to neurostimulator, leads and extensions.
| Time Interval | Survival (95% Confidence Interval) |
Sample Size |
|---|---|---|
| 1 yr | 99.1% (97.1%, 99.7%) |
202 |
| 2 yrs | 98.4% (95.7%, 99.4%) |
114 |
| 3 yrs | 97.5% (93.6%, 99.1%) |
68 |
| 4 yrs | 97.5% (93.6%, 99.1%) |
44 |
| at 57 mo | 97.5% (93.6%, 99.1%) |
24 |
Model 37612 Activa RC: Specifications
| Height | 2.1 in (54 mm) |  |
| Width | 2.1 in (54 mm) | |
| Thickness | 0.4 in (9 mm) | |
| Volume | 22 cc | |
| Battery type | Rechargeable | |
| Expected Battery life | 9 years | |
| Maximum Electrodes | 8 | |
| Amplitude | 0 - 10.5 V (voltage mode) 0 - 25.5 mA (current mode) | |
| Rate | 2 - 250 Hz (voltage mode) 30 - 250 Hz (current mode) | |
| Pulse Width | 60 - 450 μsec | |
| Groups | 4 | |
| Programs | 16 (up to 4 per group) | |
| Implant Depth | ≤ 1 cm |
Leads
From July 2009 to the report cut-off date of October 31, 2017, there were 4,045 leads followed in the registry. Differences between the total number of leads versus the total number of neurostimulators (N=3,150) were due to the fact that some patients were implanted with more than 1 lead or were subsequently re-implanted with a new lead or neurostimulator. The aggregate prospective follow-up time for all leads was 96,979 months (8,082 years). The table below provides the number and percentage of leads by model.
Leads by Model |
|
|---|---|
Model Number |
Number of Leads (%) |
| 3389 (compact electrode spacing) | 2,310 (57.1%) |
| 3387 (standard electrode spacing) | 1,693 (41.9%) |
| 3391 (large electrodes and wide spacing) | 25 (0.6%) |
| Other/Unspecified a | 17 (0.4%) |
Total |
4,045 (100%) |
a Includes leads used in non-Activa systems
Of the 205 product performance events, there were 98 product performance-related events with an underlying reported etiology related to the lead.
- Of these, 82 events had a lead etiology (36.3%) and 16 events had both a lead and other etiology (including device and non-device etiologies).
- 72 were the first event attributable to that enrolled lead
Events were characterized as follows: Fifty-four events were high impedance, 17 were lead migration/dislodgment, 16 were lead fracture, 4 were lead low impedance, 2 were device malfunction, 2 were device defective, 2 were extension fractures, and 1 was medical device complication.
For the purposes of survival analysis, a device’s follow-up time is cut-off for one of three reasons: 1) the occurrence of a product performance-related event; 2) the occurrence of a censoring event; or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off. For leads:
- 72 had follow-up time cut-off due to product performance-related events.
- 1,076 were censored in the survival analysis for the following reasons: patient expired, neurostimulator explanted, patient discontinued, therapy suspended, or site discontinued participation in the registry.
- 2,897 were free from product performance-related events and censoring events, were censored at the last follow-up prior to the report cut-off.
The figure and tables below represent lead survival and 95% confidence intervals where at least 20 leads contributed to each 3-month interval.
Model 3387: Survival from Lead Events
Data are shown if there are at least 20 devices in each 3-month interval.
Lead Characteristics |
|
|---|---|
| Model Number | 3387 |
| FDA Approval Date | Jan 2002 |
| Leads Enrolled | 1,693 |
| Leads Currently Active in Study | 1,156 |
| Device Events | 17 |
| Cumulative Months of Follow-up | 40,644 |
Model 3387: Event Summary Table |
|
|---|---|
Lead Event |
Total |
| High impedance | 7 |
| Lead migration/dislodgement | 4 |
| Lead fracture | 3 |
| Low impedance | 1 |
| Extension fracture | 1 |
| Medical device complicationa | 1 |
| Total Lead Events | 17 |
a Reported as open circuit of lead.
| Time Interval | Survival (95% Confidence Interval) |
Sample Size |
|
|---|---|---|---|
| 1 yr | 99.3% (98.6%, 99.6%) |
977 |
|
| 2 yrs | 99.1% (98.4%, 99.5%) |
592 |
|
| 3 yrs | 99.1% (98.4%, 99.5%) |
391 |
|
| 4 yrs | 99.1% (98.4%, 99.5%) |
226 |
|
| 5 yrs | 97.4% (94.4%, 98.8%) |
154 |
|
| 6 yrs | 97.4% (94.4%, 98.8%) |
81 |
|
| 7 yrs | 97.4% (94.4%, 98.8%) |
61 |
|
| 8 yrs | 96.0% (90.6%, 98.3%) |
63* |
|
| 9 yrs | 96.0% (90.6%, 98.3%) |
52 |
|
| 10 yrs | 94.1% (86.5%, 97.5%) |
45 |
|
| 11 yrs | 94.1% (86.5%, 97.5%) |
32 |
|
| at 138 mo | 90.7% (78.3%, 96.2%) |
20 |
* Due to enrollment of replacement patients with previously implanted leads, sample size may increase at later timepoints.
Model 3387: Specifications
Model Number |
3387 |
 |
|---|---|---|
Lead |
||
| Length (cm) | 40 | |
| Diameter (mm) | 1.27 | |
Electrode |
||
| Number | 4 | |
| Shape | Cylindrical | |
| Length (mm) | 1.5 | |
| Individual Surface Area (mm2) | 6.0 | |
| Inter-Electrode Spacing: Edge to Edge (mm) | 1.5 | |
| Array Length (mm) | 10.5 | |
Model 3389: Survival from Lead Events
Data are shown if there are at least 20 devices in each 3-month interval.
Lead Characteristics |
|
|---|---|
| Model Number | 3389 |
| FDA Approval Date | Sep 1999 |
| Leads Enrolled | 2,310 |
| Leads Currently Active in Study | 1,745 |
| Device Events | 52 |
| Cumulative Months of Follow-up | 55,327 |
Model 3389: Event Summary Table |
|
|---|---|
Lead Event |
Total |
| High impedance | 34 |
| Lead migration/dislodgement | 7 |
| Lead fracture | 6 |
| Low impedance | 3 |
| Device defective | 1 |
| Extension fracture | 1 |
| Total Lead Events | 52 |
| Time Interval | Survival (95% Confidence Interval) |
Sample Size |
|---|---|---|
| 1 yr | 98.8% (98.2%, 99.3%) |
1243 |
| 2 yrs | 98.1% (97.2%, 98.7%) |
775 |
| 3 yrs | 97.3% (96.1%, 98.2%) |
494 |
| 4 yrs | 96.1% (94.3%, 97.3%) |
332 |
| 5 yrs | 95.0% (92.8%, 96.6%) |
240 |
| 6 yrs | 92.4% (89.2%, 94.8%) |
171 |
| 7 yrs | 91.8% (88.2%, 94.3%) |
136 |
| 8 yrs | 91.1% (87.2%, 93.9%) |
120 |
| 9 yrs | 91.1% (87.2%, 93.9%) |
89 |
| 10 yrs | 89.8% (84.8%, 93.2%) |
52 |
| 11 yrs | 89.8% (84.8%, 93.2%) |
46 |
| 12 yrs | 89.8% (84.8%, 93.2%) |
39 |
| 13 yrs | 89.8% (84.8%, 93.2%) |
36 |
| 14 yrs | 89.8% (84.8%, 93.2%) |
25 |
| at 177 mo | 89.8% (84.8%, 93.2%) |
22 |
Model 3389: Specifications
Model Number |
3389 |
 |
|---|---|---|
Lead |
||
| Length (cm) | 40 | |
| Diameter (mm) | 1.27 | |
Electrode |
||
| Number | 4 | |
| Shape | Cylindrical | |
| Length (mm) | 1.5 | |
| Individual Surface Area (mm2) | 6.0 | |
| Inter-Electrode Spacing: Edge to Edge (mm) | 0.5 | |
| Array Length (mm) | 7.5 | |
Lead Survival SummaryLead Survival Summary
Lead Characteristics |
||||||
|---|---|---|---|---|---|---|
| Model Number | Family |
FDA Approval Date |
Leads Enrolled |
Leads Currently Active in Study |
Device Eventsa |
Cumulative Months of Follow-up |
| 3387 | 3387 |
Jan 2002 |
1,693 |
1,156 |
17 |
40,644 |
| 3389 | 3389 |
Sep 1999 |
2,310 |
1,745 |
52 |
55,327 |
a There were a total of 98 lead-related events reported to the registry, but only 69 events included in this summary table. The remaining lead-related events occurred in a lead model for which no device survival data are presented due to an insufficient number of enrolled devices (n=3) or were subsequent events (i.e. additional events that occurred after the survival censoring event) that did not affect the device survival estimates.
Device Survival Probability (95% Confidence Interval) – Table 1 of 3 |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Model Number |
Family |
1 yr |
2 yrs |
3 yrs |
4 yrs |
5 yrs |
||||||
| 3387 | 3387 |
99.3% (98.6%, 99.6%) |
99.1% (98.4%, 99.5%) |
99.1% (98.4%, 99.5%) |
99.1% (98.4%, 99.5%) |
97.4% (94.4%, 98.8%) |
||||||
| 3389 | 3389 |
98.8% (98.2%, 99.3%) |
98.1% (97.2%, 98.7%) |
97.3% (96.1%, 98.2%) |
96.1% (94.3%, 97.3%) |
95.0% (92.8%, 96.6%) |
||||||
Device Survival Probability (95% Confidence Interval) – Table 2 of 3 |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Model Number |
Family |
6 yrs |
7 yrs |
8 yrs |
9 yrs |
10 yrs |
||||
| 3387 | 3387 |
97.4% (94.4%, 98.8%) |
97.4% (94.4%, 98.8%) |
96.0% (90.6%, 98.3%) |
96.0% (90.6%, 98.3%) |
94.1% (86.5%, 97.5%) |
||||
| 3389 | 3389 |
92.4% (89.2%, 94.8%) |
91.8% (88.2%, 94.3%) |
91.1% (87.2%, 93.9%) |
91.1% (87.2%, 93.9%) |
89.8% (84.8%, 93.2%) |
||||
Device Survival Probability (95% Confidence Interval) – Table 3 of 3 |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Model Number |
Family |
11 yrs |
12 yrs |
13 yrs |
14 yrs |
at 177 mo |
||||
| 3387 | 3387 |
94.1% (86.5%, 97.5%) |
- |
- |
- |
- |
||||
| 3389 | 3389 |
89.8% (84.8%, 93.2%) |
89.8% (84.8%, 93.2%) |
89.8% (84.8%, 93.2%) |
89.8% (84.8%, 93.2%) |
89.8% (84.8%, 93.2%) |
||||
Extensions
From July 2009 to the report cut-off date of October 31, 2017, there were 4,084 extensions followed in the registry. Differences between the total number of extensions versus the total number of neurostimulators (N=3,150) were due to the fact that some patients were implanted with more than 1 extension or subsequently re-implanted with an extension or neurostimulator replacement. In addition, the number of extensions does not equal the number of leads (N=4,045) because some patients were re-implanted with a new lead using existing extensions. The aggregate prospective follow-up time for all extensions was 96,076 months (8,006 years).The table below provides the number and percentage of extensions by model.
Extensions by Model |
|
|---|---|
Model Number |
Number of Extensions (%) |
| 37086 a (quadripolar stretch) | 3,503 (85.8%) |
| Other/Unspecified b | 113 (2.8%) |
Extensions No Longer Manufactured | |
| 7482 c (quadripolar) | 468 (11.5%) |
Total | 4,084 (100%) |
a Includes Models 37085 and 37086
b Includes extensions for other legacy stimulation systems
c Includes Models 7482 and 7482a
Extension EventsExtension Events
Of the total of 205 product performance events, there were 42 product performance-related events with an underlying reported etiology related to the extension.
- Of these, 36 events had an extension etiology (15.9%) and 6 events had both an extension and other etiology (including device and non-device etiologies).
- 39 were the first event attributable to that enrolled extension.
Events are characterized as follows: Twenty events were high impedance attributed to the extensions, 5 were extension migrations, 4 were medical device complications, 3 were extension fractures, 3 were increased impedance attributed to an extension, 2 were device malfunctions, 2 were device migrations attributed to the extensions, 2 were low impedance attributed to an extension, and 1 was a device connection issue.
For the purposes of survival analysis, a device’s follow-up time is cut-off for one of three reasons: 1) the occurrence of a product performance-related event; 2) the occurrence of a censoring event; or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off. For extensions:
- 39 extensions had follow-up time cut-off due to product performance-related events.
- 1,137 were censored in the survival analysis for the following reasons: patient expired, extension explanted, site termination, patient discontinued, or therapy suspended.
- 2,908 were free from product performance-related events and censoring events, were censored at the last follow-up visit prior to the report cut-off.
Extension Survival Extension Survival
The figure and tables below represent extension survival and 95% confidence intervals where at least 20 extensions contributed to each 3-month interval.
Model 37086: Survival from Extension Events
Data are shown if there are at least 20 devices in each 3-month interval.
Extension Characteristics |
|
|---|---|
| Model Number | 37086 |
| FDA Approval Date | Sep 2009 |
| Extensions Enrolled | 3,503 |
| Extensions Currently Active in Study | 2,531 |
| Device Events | 32 |
| Cumulative Months of Follow-up | 80,005 |
Model 37086 Extension: Event Summary Table |
|
|---|---|
Extension Event |
Total |
| High impedance | 18 |
| Extension migration | 5 |
| Medical device complicationa | 4 |
| Extension fracture | 2 |
| Low impedance | 2 |
| Impedance increasedb | 1 |
| Total Extension Events | 32 |
a Includes 2 events for extension cable loop, and 2 events for twisting of extensions.
b Reported as increased impedance attributed to the neurostimulator and extension.
| Time Interval | Survival (95% Confidence Interval) |
Sample Size |
|---|---|---|
| 1 yr | 99.5% (99.1%, 99.7%) |
2,180 |
| 2 yrs | 99.1% (98.6%, 99.4%) |
1,324 |
| 3 yrs | 98.9% (98.4%, 99.3%) |
832 |
| 4 yrs | 98.8% (98.1%, 99.2%) |
471 |
| 5 yrs | 97.8% (96.2%, 98.8%) |
257 |
| 6 yrs | 97.8% (96.2%, 98.8%) |
109 |
| 7 yrs | 97.8% (96.2%, 98.8%) |
36 |
| at 90 mo | 97.8% (96.2%, 98.8%) |
21 |
Model 37086 Extension: Specifications
| Device Name | Stretch-Coil® DBS Extension |
 |
|---|---|---|
| Length (cm) | 40, 40, 95 | |
| Distal End Compatibility | 3387, 3389, or 3391 DBS lead | |
| Distal End Set Screws | 4 | |
| Proximal End INS Compatibility | Activa® RC, Activa PC, or Activa SC 37603 |
Extension Survival SummaryExtension Survival Summary
Extension Characteristics |
||||||
|---|---|---|---|---|---|---|
| Model Number | Family | FDA Approval Date | Extensions Enrolled | Extensions Currently Active in Study | Device Eventsa | Cumulative Months of Follow-up |
| 37086b | 37086 | Sep 2009 | 3,503 | 2,531 | 32 | 80,005 |
Device Survival Probability (95% Confidence Interval) |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Model Number | 1 yr | 2 yrs | 3 yrs | 4 yrs |
5 yrs |
6 yrs |
7 yrs | ||||||
| 37086b | 99.5% (99.1%, 99.7%) | 99.1% (98.6%, 99.4%) | 98.9% (98.4%, 99.3%) | 98.8% (98.1%, 99.2%) |
97.8% (96.2%, 98.8%) |
97.8% (96.2%, 98.8%) |
97.8% (96.2%, 98.8%) | ||||||
a There were a total of 42 extension-related events reported to the registry, but only 32 events included in this summary table. The remaining events occurred in an extension model for which no device data are presented due to an insufficient number of enrolled devices (n=7) or were subsequent events (i.e. additional events that occurred after the survival censoring event) that did not affect the device survival estimates or attributable to other models not included on this table.
b Includes Models 37085 and 37086.
UC201906090EN
2017 Medtronic Product Performance Report: Data through October 31, 2017.