SynchroMed II Drug Infusion System for Severe Spasticity

Catheters

Comparison of Intrathecal Catheter Models 8709SC and 8731SC

The intrathecal catheter creates a pathway for medication flowing from the pump to the drug delivery site. Medtronic intrathecal catheters come in one - and two - piece models. The silicone, radiopaque catheter body is elastic, flexible, and trimmable.

  Model 8709SC Model 8731SC
Total length 89 cm 104.1 cm
Spinal segment 81.4 cm 38.1 cm
Pump segment or SC interface 7.6 cm 66 cm
Connector pin Yes Yes
Pin type Sutureless Suture grooves
Introducer needle 15-gauge Tuohy 15-gauge Tuohy
Needle length 9.3 cm 11.4 cm/9.3 cm
Numeric markings Yes Yes
Trimmable segments Spinal Spinal/pump end

 

Indura 1P Model 8709SC

Medtronic Intrathecal Catheter Indura 1P Model 8709SC with Sutureless Connector

The Indura® 1P 8709SC intrathecal catheter consists of a one-piece catheter body and a catheter interface with the sutureless pump connector designed for use in the intrathecal space. Made of radiopaque silicone rubber, it is flexible and trimmable at the pump end of the placed catheter. The sutureless pump connector allows for connection to the pump at the catheter port.

The spinal end of the catheter has a closed tip and 6 holes for fluid delivery. To aid in catheter placement, it is marked at 1-cm increments between 12 cm and 81 cm. A guide wire in the lumen provides additional stiffness and catheter tip control during placement. The catheter can be positioned by direct percutaneous surgical procedures using the accessories provided in the catheter package.

 

Medtronic Intrathecal Catheter Indura 1P Model 8709SC with Sutureless Connector

Specifications

LENGTH
Total catheter 89 cm
Spinal segment 81.4 cm
Catheter interface with sutureless connector 7.6 cm
CATHETER
Outer diameter 1.4 mm (4.2 French)
Inner diameter 0.53 mm
Marker spacing 1 cm between 12 cm and 81 cm
CATHETER INTERFACE
Outer diameter (catheter only) 2.2 mm (6.5 French)
Inner diameter (catheter only) 0.53 mm
OTHER SPECIFICATIONS
Catheter volume 0.0022 mL/cm
Connector pin inner diameter 0.41 mm
Guide wire outer diameter 0.46 mm
Introducer needle 15-gauge Tuohy 9.3 cm
Trimmable end Pump end of the catheter
CATHETER MATERIALS
Body Radiopaque silicone rubber
Tip Closed tip, radiopaque, titanium with 6 side holes
Catheter Interface Radiopaque silicone rubber (7.6 cm)
Sutureless Pump Connector Radiopaque silicone, titanium, silicone (external component), nylon


Related Manuals & Technical Resources

This technical manual includes the instructions for use for the Indura® 1P model 8709SC.

Model 8731SC

Intrathecal Catheter
Model 8731SC with Sutureless Connector

The Model 8731SC Intrathecal Catheter is a 2-piece catheter. The catheter body is made of an elastic and flexible radiopaque silicone rubber material, and includes trimmable segments.

The sutureless connector facilitates connection to the pump at the catheter port. The pre-attached strain-relief sleeve and connector pin facilitate connection to the spinal catheter segment.

The distal end of the spinal segment has a closed tip and 6 side holes for fluid delivery. The spinal segment is marked in 1-cm increments starting at the 14-cm mark to aid in catheter placement. A guide wire in the lumen provides additional stiffness and catheter tip control during placement. The catheter can be positioned by direct percutaneous surgical procedures using the accessories provided in the catheter package.

Intrathecal Catheter

Specifications

LENGTH
Total catheter 104.1 cm
Spinal segmenta 38.1 cm
Pump segmentb 7.6 cm
SPINAL SEGMENT
Outer diametera 1.4 mm (4.2 French)
Inner diametera 0.53 mm
Marker spacinga 1 cm starting at 14 cm
Catheter tipa Closed with 6 side holes
PUMP SEGMENTS
Outer diameterb 2.2 mm (6.5 French)
Inner diameterb 0.53 mm
OTHER SPECIFICATIONS
Catheter volumea,b 0.0022 mL/cm
Connector pin 0.41 mm inner diameter
Guide wire outer diameter 0.46 mm
Introducer needle (long)a 15-gauge Tuohy (11.4 cm)
Introducer needle (short)a 15-gauge Tuohy (9.3 cm)
Trimmable segments spinal and pump segments
CATHETER MATERIALSb
Body Radiopaque silicone rubber
Tip Closed tip, radiopaque, titanium with 6 side holes
Catheter Interface Radiopaque silicone rubber (7.6 cm)
Sutureless Pump Connector Radiopaque silicone, titanium, silicone (external component), nylon

 

a Included in or applies to the Model 8598A Intrathecal Catheter Spinal Revision Kit
b Included in or applies to the Model 8596SC Pump Segment Revision Kit

Related Manuals & Technical Resources

This technical manual includes the instructions for use for the Intrathecal Catheter and Sutureless Connector model 8731SC.

For more information on the indications, contraindications, warnings, and precautions for the SynchroMed programmable infusion systems, please review the device brief summaries for the SynchroMed II Drug Infusion System and the SynchroMed EL Infusion System.

ITB TherapySM (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. For spasticity of spinal cord origin, ITB Therapy via an implantable infusion system should be reserved for patients unresponsive to oral baclofen or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long-term intrathecal baclofen therapy.

Indications, Safety & Warnings for ITB Therapy: Intrathecal Baclofen Withdrawal: Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).

This therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.

The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Pump system component failures leading to pump stall, or dosing/programming errors may result in clinically significant overdose or underdose. Acute massive overdose may result in coma and may be life threatening.

The most frequent and serious adverse events related to device and implant procedures are catheter dislodgement from the intrathecal space, catheter break/cut, and implant site infection including meningitis. Electromagnetic interference (EMI) and Magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate.

Please refer to the full prescribing information and system information for details or call Medtronic at 1-800-328-0810. Rx Only. Lioresal® is a registered trademark of Novartis Pharmaceuticals Corporation.

January 2008