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 July 31, 2016. Thirty-six centers enrolled and contributed patients to the deep brain stimulation section of the report.
Patients
Of the 2,109 deep brain stimulation patients enrolled, 67.1% were implanted for the treatment of Parkinson’s Disease, 21.3% were implanted for the treatment of Essential Tremor, 7.1% were implanted for the treatment of Dystonia, 2.0% were implanted for the treatment of some other indication, 1.6% were implanted for indications that were not specified in the database, 0.7% were implanted for the treatment of Obsessive Compulsive Disorder, and 0.2% were implanted for the treatment of Epilepsy.
Primary DBS Treatment IndicationsPrimary DBS Treatment Indications
| Primary Treatment Indicationa | Total Enrolled Patients (Percent) |
|---|---|
| Parkinson's Disease | 1,416 (67.1%) |
| Essential Tremor | 449 (21.3%) |
| Dystonia | 150 (7.1%) |
| OCD | 14 (0.7%) |
| Epilepsy | 5 (0.2%) |
| Other | 42 (2.0%) |
| Not specified | 33 (1.6%) |
| Total Patients | 2,109 |
a Refer to product labeling for approved indications.
Event Summary
There were 715 events reported between July 2009 and July 31, 2016 in patients with deep brain stimulation systems. Of these events, 17.3% (124/715) were categorized as product performance-related and are presented graphically within this report. The 124 product performance events occurred in 74 of the 2,109 total patients (3.5%) enrolled. In addition, there were 591 non-product performance events reported. There were also 78 deaths reported for patients with deep brain stimulation systems. None of these deaths were reported as a direct result of a product performance event.
| Deep Brain Stimulation System Product Performance Events | |||
| Eventa | Number of Product Performance Events |
Number of Patients with Eventb | Percent of Patients with Event (N=2,109) |
|---|---|---|---|
| High impedance | 57 | 32 | 1.5% |
| Lead fracture | 13 | 9 | 0.4% |
| Lead migration/dislodgement | 13 | 7 | 0.3% |
| Medical device complicationc | 10 | 8 | 0.4% |
| Device malfunction | 6 | 3 | 0.1% |
| Neurostimulator unable to recharged | 5 | 5 | 0.2% |
| Extension fracture | 3 | 3 | 0.1% |
| Extension migration | 3 | 2 | 0.1% |
| Low impedance | 3 | 3 | 0.1% |
| Device breakage | 2 | 2 | 0.1% |
| Device connection issue | 2 | 1 | <0.1% |
| Impedance increased | 2 | 1 | <0.1% |
| Device defective | 1 | 1 | <0.1% |
| Device failure | 1 | 1 | <0.1% |
| Device migration | 1 | 1 | <0.1% |
| Electromagnetic interference | 1 | 1 | <0.1% |
| Lead insulation breach | 1 | 1 | <0.1% |
| Totals | 124 | 74 | 3.5% |
a Medical Dictionary for Regulatory Activities (MedDRA) Preferred 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 open circuit to lead, 1 antenna heating while recharging, 1 suspicion of heating of the antenna while recharging, 1 undesirable interaction with external electronic device, 1 short circuit, and 1 issue with controller not communicating.
d There were 254 patients that used rechargeable neurostimulators for DBS in the registry. A total of 2.0% (5/254) of patients with a rechargeable neurostimulator experienced a neurostimulator unable to recharge event.
A total of 50 (40.3%) of the 124 product performance events were related to the lead, 26 (21.0%) were related to "multiple etiologies", which includes events where at least one device and one non-device etiology was indicated, 18 (14.5%) were related to the extension, 9 (7.3%) were related to the neurostimulator, 6 (4.8%) were related to the recharging process, 6 (4.8%) were related to surgery/anesthesia, 5 (4.0%) were related to other devices, 3 (2.4%) were related to programming/stimulation, and 1 (0.8%) was related to some "other" etiology. Relatedness is determined by the physician.
Product Performance Events by Relatednessa
a Each event could have more than one etiology.
| 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) | 83 |
| Tremor | 37 |
| Dyskinesia | 21 |
| Dystonia | 12 |
| Bradykinesia | 3 |
| Parkinson's disease | 3 |
| Otherc | 7 |
| Infections - pathogen unspecified | 79 |
| Implant site infection | 51 |
| Postoperative wound infection | 6 |
| Wound infection | 6 |
| Device related infection | 4 |
| Infection | 4 |
| Otherc | 8 |
| Device issues | 75 |
| Device stimulation issue | 39 |
| Neurostimulator migration | 16 |
| Neurostimulator unable to recharged | 4 |
| Battery recharge issue | 3 |
| Otherc | 13 |
| Neurological disorders Not Elsewhere Classified (NEC) | 56 |
| Dysarthria | 17 |
| Paraesthesia | 12 |
| Balance disorder | 9 |
| Speech disorder | 9 |
| Otherc | 9 |
| Administration site reactions | 42 |
| Implant site pain | 10 |
| Implant site erosion | 9 |
| Implant site inflammation | 6 |
| Implant site haematoma | 4 |
| Otherc | 13 |
| Depressed mood disorders and disturbances | 32 |
| Depression | 30 |
| Otherc | 2 |
| Procedural related injuries and complications NEC | 25 |
| Wound dehiscence | 14 |
| Otherc | 11 |
| Injuries NEC | 22 |
| Fall | 9 |
| Subdural haematoma | 6 |
| Otherc | 7 |
| General system disorders NEC | 17 |
| Gait disturbance | 9 |
| Pain | 3 |
| Otherc | 5 |
| Anxiety disorders and symptoms | 11 |
| Anxiety | 8 |
| Otherc | 3 |
| Deliria (including confusion) | 11 |
| Confusional state | 8 |
| Delirium | 3 |
| Psychiatric and behavioural symptoms NEC | 11 |
| Abnormal behaviour | 11 |
| Central nervous system vascular disorders | 10 |
| Cerebral haematoma | 4 |
| Haemorrhage intracranial | 4 |
| Otherc | 2 |
| Mental impairment disorders | 8 |
| Cognitive disorder | 4 |
| Otherc | 4 |
| Mood disorders and disturbances NEC | 7 |
| Apathy | 3 |
| Otherc | 4 |
| Physical examination and organ system status topics | 7 |
| Weight increased | 7 |
| Seizures (including subtypes) | 7 |
| Convulsion | 4 |
| Otherc | 3 |
| Suicidal and self-injurious behaviours NEC | 7 |
| Suicidal ideation | 5 |
| Otherc | 2 |
| Musculoskeletal and connective tissue disorders NEC | 5 |
| Musculoskeletal stiffness | 3 |
| Otherc | 2 |
| Disturbances in thinking and perception | 4 |
| Hallucination | 4 |
| Pulmonary vascular disorders | 3 |
| Pulmonary embolism | 3 |
| Otherc | 69 |
| Total | 591 |
a Adverse events associated with product performance events are not included in this table.
b Medical Dictionary for Regulatory Activities (MedDRA) High-Level Group Terms and Preferred Terms 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 3 events each.
d Patients were unable to recharge their neurostimulators due to an issue not related to the device.
There were 78 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 66 (84.6%) deaths occurred in patients receiving therapy for Parkinson’s disease and 12 (15.4%) for Essential Tremor.
| Death by Primary Indication | |
| Primary Indicationa | N (%) |
|---|---|
| Parkinson's Disease | 66 (84.6%) |
| Essential Tremor | 12 (15.4%) |
| Total | 78 (100%) |
a Refer to product labeling for approved indications
Neurostimulators
From July 2009 to the report cut-off date of July 31, 2016, 2,462 deep brain neurostimulators were followed in the registry. The difference between the total number of patients (N=2,109) 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 36,458 months (3,038 years). The table below provides the number and percentage of neurostimulators by model.
| Neurostimulators by Model | |
|---|---|
| Model | Number of Neurostimulators (%) |
| Activa PC (37601) | 1,440 (58.5%) |
| Activa SC (37602/37603) | 663 (26.9%) |
| Activa RC (37612) | 257 (10.4%) |
| Other/Unspecified | 22 (0.9%) |
| Neurostimulators No Longer Manufactured | |
| Soletra (7426) | 68 (2.8%) |
| Kinetra (7428) | 12 (0.5%) |
| Total | 2,462 (100%) |
Neurostimulator Events Neurostimulator Events
There were 12 product performance-related events with an underlying reported etiology related to deep brain neurostimulator function. This includes 9 events with a neurostimulator etiology, and 3 with both a neurostimulator and other etiology (including device and non-device etiologies). All 12 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) was 28/409 (6.8%). 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. There were no anomalies found in the 28 devices that were returned for analysis. The 12 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=5), device malfunction (n=2), medical device complication (n=2), device connection issue (n=1), electromagnetic interference (n=1), and impedance increased (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 non-product performance-related or 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:
- 12 had follow-up time cut-off due to a product performance-related event.
- 852 were censored in the survival analysis for the following reasons: patient expired, neurostimulator explanted, patient discontinued, therapy suspended, other neurostimulator modification, site termination, or non-product performance neurostimulator-related event without an associated intervention.
- 1,598 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 | 1,440 |
| Neurostimulators Currently Active in Study | 1,031 |
| Device Events | 7 |
| Cumulative Months of Follow-up | 20,638 |
| Model Activa PC: Event Summary Table | |
|---|---|
| Neurostimulator Event | Total |
| Device malfunction | 2 |
| Device connection issuee | 1 |
| Electromagnetic interference | 1 |
| High impedancea | 1 |
| Impedance increasedb | 1 |
| Medical device complicationc | 1 |
| Total Neurostimulator Events | 7 |
a Reported as high impedance attributed to leads, neurostimulator and extensions.
bReported as increased impedance attributed to the neurostimulator and extension.
cReported as undesirable interaction with external electronic device.
| Time Interval | Survival (95% Confidence Interval) | Sample Size |
|---|---|---|
| 1 yr | 99.6% (99.0%, 99.9%) | 706 |
| 2 yrs | 99.3% (98.3%, 99.7%) | 285 |
| 3 yrs | 99.3% (98.3%, 99.7%) | 106 |
| 4 yrs | 99.3% (98.3%, 99.7%) | 27 |
| at 51 mo | 99.3% (98.3%, 99.7%) | 23 |
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 (additional Information) | |
| 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 | 663 |
| Neurostimulators Currently Active in Study | 387 |
| Device Events | 3 |
| Cumulative Months of Follow-up | 9,725 |
| Model Activa SC: Event Summary Table | |
|---|---|
| Neurostimulator Event | Total |
| High impedancea | 2 |
| Medical device complicationb | 1 |
| Total Neurostimulator Events | 3 |
a Includes 2 events 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 | 99.4% (98.0%, 99.8%) | 327 |
| 2 yrs | 99.4% (98.0%, 99.8%) | 159 |
| 3 yrs | 99.4% (98.0%, 99.8%) | 54 |
| at 45 mo | 99.4% (98.0%, 99.8%) | 27 |
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 (additional Information) | |
| 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 | 257 |
| Neurostimulators Currently Active in Study | 175 |
| Device Events | 2 |
| Cumulative Months of Follow-up | 4,268 |
| Model Activa RC: Event Summary Table | |
|---|---|
| Neurostimulator Event | Total |
| High impedancea | 2 |
| Total Neurostimulator Events | 2 |
aIncludes 1 events reported as high impedance attributed to the neurostimulator, extension and lead, and 1 for high impedance attributed to the neurostimulator.
| Time Interval | Survival (95% Confidence Interval) | Sample Size |
|---|---|---|
| 1 yr | 99.5% (96.8%, 99.9%) | 132 |
| 2 yrs | 98.6% (94.0%, 99.7%) | 69 |
| 3 yrs | 98.6% (94.0%, 99.7%) | 38 |
| at 42 mo | 98.6% (94.0%, 99.7%) | 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 |
Model 7426 Soletra: Survival from Neurostimulator Events
| Deep Brain Neurostimulator Characteristics | |
|---|---|
| Model Name | Soletra |
| FDA Approval Date | Jan 2002 |
| Neurostimulators Enrolled | 68 |
| Neurostimulators Currently Active in Study | 4 |
| Device Events | 0 |
| Cumulative Months of Follow-up | 1,427 |
| Time Interval | Survival (95% Confidence Interval) | Sample Size |
|---|---|---|
| 1 yr | 100.0% (NA) | 44 |
| 2 yrs | 100.0% (NA) | 27 |
| 27 mo | 100.0% (NA) | 20 |
Model 7426 Soletra: Specifications
| Height | 2.2 in (55 mm) |  |
| Width | 2.4 in (60 mm) | |
| Thickness | 0.4 in (10 mm) | |
| Volume | 22 cc | |
| Battery type | Non-rechargeable | |
| Expected Battery life | Depends on settings and use (additional Information) | |
| Maximum Electrodes | 4 | |
| Amplitude | 0 - 10.5 V | |
| Rate | 3 - 185 Hz | |
| Pulse Width | 30 - 450 μsec | |
| Groups | 1 | |
| Programs | 1 | |
| Implant Depth | ≤ 4 cm |
Deep Brain Neurostimulator Survival Summary Deep Brain Neurostimulator Survival Summary
| Deep Brain Neurostimulator Characteristics | ||||||
|---|---|---|---|---|---|---|
| Model Name | Family | FDA Approval Date | Neuro- stimulators Enrolled | Neuro- stimulators Currently Active in Study | Device Events | Cumulative Months of Follow-up |
| Activa PC | Activa | Apr 2009 | 1,440 | 1,031 | 7 | 20,638 |
| Activa SC | Activa | Jan 2011 | 663 | 387 | 3 | 9,725 |
| Activa RC | Activa | Mar 2009 | 257 | 175 | 2 | 4,268 |
| Soletra | Soletra | Jan 2002 | 68 | 4 | 0 | 1,427 |
| Device Survival Probability (95% Confidence Interval) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Model Name | 1 yr | 2 yrs | 3 yrs | 4 yrs | |||||
| Activa PC | 99.6% (99.0%, 99.9%) | 99.3% (98.3%, 99.7%) | 99.3% (98.3%, 99.7%) | 99.3% (98.3%, 99.7%) | |||||
| Activa SC | 99.4% (98.0%, 99.8%) | 99.4% (98.0%, 99.8%) | 99.4% (98.0%, 99.8%) | - | |||||
| Activa RC | 99.5% (96.8%, 99.9%) | 98.6% (94.0%, 99.7%) | 98.6% (94.0%, 99.7%) | - | |||||
| Soletra | 100.0% (NA) | 100.0% (NA) | - | - | |||||
Leads
From July 2009 to the report cut-off date of July 31, 2016, there were 3,293 leads followed in the registry. Differences between the total number of leads versus the total number of neurostimulators (N=2,462) were due to the fact that some patients were implanted with more than 1 lead or were subsequently re-implanted with a new lead. The aggregate prospective follow-up time for all leads was 57,102 months (4,758 years).
A lead is a set of thin wires with a protective coating and electrodes near the tip. The table below provides the number and percentage of leads by model.
| Leads by Model | |
|---|---|
| Model Number | Number of Leads (%) |
| 3389 (compact electrode spacing) | 1,852 (56.2%) |
| 3387 (standard electrode spacing) | 1,408 (42.8%) |
| 3391 | 22 (0.7%) |
| Other/Unspecified | 11 (0.3%) |
| Total | 3,293 (100%) |
There were 66 product performance-related events with an underlying reported etiology related to the lead. This includes 50 events with a lead etiology and 16 events with both a lead and other etiology (including device and non-device etiologies). Thirty-seven events were high impedance, 13 were lead fracture, 8 were lead migration/dislodgement, 3 were low impedance, 2 were device malfunction, 1 was medical device complication, 1 was device defective, and 1 was device failure. Of the 66 events, 38 were the initial product performance event that affected lead survival estimates.
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 non-product performance-related or 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:
- 38 had follow-up time cut-off due to product performance-related events.
- 828 were censored in the survival analysis for the following reasons: patient expired, lead explanted, patient discontinued, site termination, therapy suspended, or other lead modification, or non-product performance lead-related event without an associated intervention.
- 2,427 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 | 1,408 |
| Leads Currently Active in Study | 994 |
| Device Events | 10 |
| Cumulative Months of Follow-up | 25,137 |
| Model 3387: Event Summary Table | |
|---|---|
| Lead Event | Total |
| High impedance | 6 |
| Lead fracture | 1 |
| Low impedance | 1 |
| Lead migration/dislodgement | 1 |
| Medical device complicationa | 1 |
| Total Lead Events | 10 |
a Reported as open circuit of lead.
| Time Interval | Survival (95% Confidence Interval) |
Sample Size |
|---|---|---|
| 1 yr | 99.3% (98.5%, 99.7%) |
675 |
| 2 yrs | 99.1% (98.0%, 99.6%) |
341 |
| 3 yrs | 99.1% (98.0%, 99.6%) |
187 |
| 4 yrs | 99.1% (98.0%, 99.6%) |
114 |
| 5 yrs | 97.8% (92.9%, 99.3%) |
49 |
| 6 yrs | 97.8% (92.9%, 99.3%) |
32 |
| 7 yrs | 97.8% (92.9%, 99.3%) |
42 |
| 8 yrs | 97.8% (92.9%, 99.3%) |
38 |
| 9 yrs | 97.8% (92.9%, 99.3%) |
29 |
| at 117 mo | 94.2% (80.4%, 98.4%) |
20 |
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 | 1,852 |
| Leads Currently Active in Study | 1,440 |
| Device Events | 27 |
| Cumulative Months of Follow-up | 31,496 |
| Model 3389: Event Summary Table | |
|---|---|
| Lead Event | Total |
| High impedance | 18 |
| Lead fracture | 5 |
| Lead migration/dislodgement | 2 |
| Device defective | 1 |
| Low impedance | 1 |
| Total Lead Events | 27 |
| Time Interval | Survival (95% Confidence Interval) |
Sample Size |
|---|---|---|
| 1 yr | 99.0% (98.2%, 99.4%) |
779 |
| 2 yrs | 98.1% (96.9%, 98.9%) |
398 |
| 3 yrs | 97.5% (95.8%, 98.5%) |
234 |
| 4 yrs | 96.3% (93.7%, 97.9%) |
148 |
| 5 yrs | 95.6% (92.2%, 97.5%) |
118 |
| 6 yrs | 93.0% (88.1%, 95.9%) |
95 |
| 7 yrs | 93.0% (88.1%, 95.9%) |
85 |
| 8 yrs | 93.0% (88.1%, 95.9%) |
59 |
| 9 yrs | 93.0% (88.1%, 95.9%) |
28 |
| at 111 mo | 93.0% (88.1%, 95.9%) |
23 |
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 | 1,408 | 994 | 10 | 25,137 |
| 3389 | 3389 | Sep 1999 | 1,852 | 1,440 | 27 | 31,496 |
a There were a total of 66 lead-related events reported to the registry, but only 37 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=1) 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 2 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Model Number |
Family | 1 yr | 2 yrs | 3 yrs | 4 yrs | ||||||
| 3387 | 3387 | 99.3% (98.5%, 99.7%) |
99.1% (98.0%, 99.6%) |
99.1% (98.0%, 99.6%) |
99.1% (98.0%, 99.6%) |
||||||
| 3389 | 3389 | 99.0% (98.2%, 99.4%) |
98.1% (96.9%, 98.9%) |
97.5% (95.8%, 98.5%) |
96.3% (93.7%, 97.9%) |
||||||
| Device Survival Probability (95% Confidence Interval) – Table 2 of 2 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Model Number |
Family | 5 yrs | 6 yrs | 7 yrs | 8 yrs | 9 yrs | ||||
| 3387 | 3387 | 97.8% (92.9%, 99.3%) |
97.8% (92.9%, 99.3%) |
97.8% (92.9%, 99.3%) |
97.8% (92.9%, 99.3%) |
97.8% (92.9%, 99.3%) |
||||
| 3389 | 3389 | 95.6% (92.2%, 97.5%) |
93.0% (88.1%, 95.9%) |
93.0% (88.1%, 95.9%) |
93.0% (88.1%, 95.9%) |
93.0% (88.1%, 95.9%) |
||||
Extensions
From July 2009 to the report cut-off date of July 31, 2016, there were 3,307 extensions followed in the registry. Differences between the total number of extensions versus the total number of neurostimulators (N=2,462) were due to the fact that some patients were implanted with more than 1 extension or subsequently re-implanted with an extension. In addition, the number of extensions does not equal the number of leads (N=3,293) because some patients were re-implanted with a new lead using existing extensions. The aggregate prospective follow-up time for all extensions was 56,121 months (4,677 years).
An extension is a set of thin wires with a protective coating that connects the neurostimulator to the lead. The table below provides the number and percentage of extensions by model.
| Extensions by Model | |
|---|---|
| Model | Number of Extensions (%) |
| 37086a (quadripolar stretch) | 2,782 (84.1%) |
| Other/Unspecified | 94 (2.8%) |
| Extensions No Longer Manufactured | |
| 7482 (quadripolar) | 431 (13.0%) |
| Total | 3,307 (100%) |
a Includes Models 37085 and 37086
Extension EventsExtension Events
There were 23 product performance-related events with an underlying reported etiology related to the extension. This includes 18 events with an extension etiology and 5 events with both an extension and other etiology (including device and non-device etiologies). Eleven events were high impedance attributed to the extensions, 4 were medical device complications, 3 were extension fractures, 2 were extension migrations, 1 was device malfunction, 1 was device connection issue, and 1 was impedance increased. Of the 23 events, 15 were the initial product performance event that affected extension survival estimates.
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 non-product performance-related or 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:
- 15 extensions had follow-up time cut-off due to product performance-related events.
- 850 were censored in the survival analysis for the following reasons: patient expired, extension explanted, site termination, patient discontinued, therapy suspended, other extension modification, or non-product performance extension-related event without an associated intervention.
- 2,442 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 | 2,782 |
| Extensions Currently Active in Study | 2,063 |
| Device Events | 15 |
| Cumulative Months of Follow-up | 46,254 |
| Model 37086 Extension: Event Summary Table | |
|---|---|
| Extension Event | Total |
| High impedance | 7 |
| Medical device complicationa | 4 |
| Extension migration | 2 |
| Extension fracture | 1 |
| Impedance increasedb | 1 |
| Total Extension Events | 15 |
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% (99.0%, 99.7%) | 1,407 |
| 2 yrs | 99.3% (98.8%, 99.6%) | 699 |
| 3 yrs | 99.3% (98.8%, 99.6%) | 378 |
| 4 yrs | 99.3% (98.8%, 99.6%) | 190 |
| 5 yrs | 98.3% (94.7%, 99.5%) | 57 |
| at 69 mo | 98.3% (94.7%, 99.5%) | 29 |
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 | 2,782 | 2,063 | 15 | 46,254 |
| Device Survival Probability (95% Confidence Interval) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Model Number | 1 yr | 2 yrs | 3 yrs | 4 yrs | 5 yrs | ||||||
| 37086b | 99.5% (99.0%, 99.7%) | 99.3% (98.8%, 99.6%) | 99.3% (98.8%, 99.6%) | 99.3% (98.8%, 99.6%) | 98.3% (94.7%, 99.5%) | ||||||
a There were a total of 23 extension-related events reported to the registry, but only 15 events included in this summary table. The remaining events were subsequent events that did not affect the device survival estimates.
b Includes Models 37085 and 37086
2016 Medtronic Product Performance Report: Data through July 31, 2016.