SynchroMed II Drug Infusion System for Severe Spasticity

Programmers & Accessories

Clinician Programmers

N'Vision Clinician Programmer Model 8840

The Medtronic N'Vision® clinician programmer model 8840 is a portable device that offers a single programming platform for the Medtronic implantable drug delivery and neurostimulation devices.

The clinician programmer is an external component of the system used to program the implanted intrathecal drug delivery system. The programmer is equipped with a touchscreen display for data entry, telemetry head for device programming, and an infrared port through which communications can be established with compatible printers.

N'Vision Clinician Programmer Model 8840

Features

  • Read and change settings from the implanted intrathecal drug delivery system
  • Print patient records using the portable printer or a standard office laser printer
  • Store information from up to 100 visits

Specifications

 
Power source Four AA commercially available alkaline batteries (LR6) (Do not use rechargeable batteries.)
Battery life Approximately 40 hours (with fresh batteries)
Clock back-up battery Type BR1225 lithium coin cell
Length 22 cm (8.75 in.)
Width 10 cm (3.75 in.)
Height 4 cm (1.60 in.)
Weight
(without batteries)		 680 g (24 oz or less)
Case material Thermoplastic resin and magnesium
Telemetry cable 90-100 cm (36-40 in.)
Screen color 4 shades of gray
Screen size 240 x 640 pixels
Serial interface IR communication link (IrDA 1.0)

Related Manuals & Technical Resources

  • N'Vision Clinican Programmer Technical Manual

    This manual presents information for users of the N'Vision Clinician Programmer, model 8840 including an overview and description, as well as the use, maintenance, troubleshooting, and specifications of the programmer.

Refill Kits

The Lioresal® Intrathecal (baclofen injection) Refill Kits Model 856X (see chart below for list of model numbers) are intended for use in refilling Medtronic programmable implantable infusion pumps. The drug volume and concentration depend on the specific kit model number. These kits are only available in the U.S.

Kit model number Drug volume Drug concentration

8561

20 mL

500 micrograms/mL

8562

10mL, 2 x 5 mL

2000 micrograms/mL

8564

20 mL

2000 micrograms/mL

8565

40 mL, 2 x 20 mL

500 micrograms/mL

8566

40 mL, 2 x 20 mL

2000 micrograms/mL

Revision Kits

8578 Sutureless Pump Connector Revision Kit

The Model 8578 Sutureless Pump Connector Revision Kit is used when a revision to the pump connector of an Indura® 1P Model 8709 or Model 8709SC catheter is required. The catheter interface facilitates connection to the pump at the catheter port and relieves strain on the catheter segment near the pump connection.

N'Vision Clinician Programmer Model 8840

Package Contents:

  • 1 catheter interface (non-trimmable) with pre-attached sutureless pump connector, strain-relief sleeve, and connector pin (without suture grooves)
  • 2 transparent spinal segment strain-relief sleeves
  • 1 ruler (non-sterile)

8596SC Intrathecal Catheter Proximal Revision Kit

The 8596SC Intrathecal Cathetar Proximal Revision Kit is used when a revision to the pump segment of the Model 8731 or Model 8731SC catheter is required.

8596SC Pump Segment Revision Kit

Package Contents:

  • 1 pump catheter segment with pre-attached sutureless (trimmable) pump connector (66 cm)
  • 2 opaque pump segment strain-relief sleeves
  • 2 transparent spinal segment strain-relief sleeves
  • 1 connector pin (with suture grooves)
  • 1 ruler (non-sterile)

8598A Intrathecal Catheter Distal Revision Kit

The Model 8598A Intrathecal Catheter Distal Revision Kit provides replacement parts for the spinal section of the Model 8731 intrathecal catheter and Model 8731SC intrathecal catheter.

8598A Intrathecal Catheter Spinal Segment Revision Kit

Package Contents:

  • 1 spinal catheter section with inserted guide wire (38.1 cm)
  • (2) 15-gauge Tuohy spinal needles (11.4 cm and 9.3 cm)
  • 2 transparent spinal segment strain-relief sleeves
  • 2 opaque pump segment strain-relief sleeves
  • 1 v-wing anchor
  • 1 connector pin with suture grooves
  • 1 ruler (non-sterile)

Related Manuals & Technical Resources

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