SynchroMed EL Drug Infusion System for Severe Spasticity
Manuals & Technical Resources
Clinician Manuals
- Catheter Access Port Kits Technical Manual
Catheter Access Port Kits for use with Medtronic Implantable Infusion Pumps instructions for use.
- Indications, Drug Stability and Emergency Procedures Reference Manual
This reference manual contains information specifically regarding indications, drug stability and emergency procedures for the SynchroMed® and IsoMed® Infusion Systems.
- Intrathecal Catheter Indura 1P Implant Manual
This implant manual includes the instructions for use for the Indura® 1P model 8709SC.
- Intrathecal Catheter with Sutureless Connector Implant Manual
This implant manual includes the instructions for use for the Intrathecal Catheter and Sutureless Connector model 8731SC.
- 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.
- Sutureless Pump Connector Revision Kit Implant Manual
Instructions for use for the Sutureless Pump Connector Revision Kit for model 8709 and model 8709SC intrathecal catheters.
- SynchroMed EL Programmable Infusion System Technical Manual
This is the instructions for use for the SynchroMed EL Programmable drug infusion system model 8627.
Patient Manuals
- SynchroMed EL Programmable Infusion System Patient Manual
This is the instructions for use for the SynchroMed EL Programmable drug infusion system model 8627.
Technical Resources
- Bridge Bolus Calculation Reference Card
Whenever there is a change in drug concentration or solution, the remaining old drug in the pump tubing and catheter must be accounted for to prevent under- or overdosing the patient while the old drug concentration is being cleared from the fluid pathway. This reference card outlines how to calculate a bridge bolus.
- ITB Therapy (Intrathecal Baclofen Therapy) Product Monograph
The monograph includes information regarding clinical pharmacology, warnings & precautions, clinical trials and other detailed information regarding ITB TherapySM .
- Lioresal Underdose and Overdose Emergency Procedure Card
Emergency procedure information for underdose and overdose of Lioresal® Intrathecal (baclofen injection).
- N'Vision Clinician Programmer and the SynchroMed Programmable Infusion System Quick Start Guide
This guide provides an overview of operating N'Vision software. Includes a description of programming parameters and calculations.
- N'Vision Quick Start Guide: Global Functions
This guide provides an overview of how to operate the N'Vision Clinician Programmer.
Medtronic has confirmed through engineering analyses that the use of indicated and nonindicated drug formulations can result in collection of CSF protein in the catheter lumen, distal end. Although this may occur with any drug, nonindicated drug formulations can result in significantly increased collections of material in the catheter lumen resulting in complete occlusion of the catheter.
Medtronic has confirmed through returned product analysis that the use of nonindicated drug formulations can compromise the performance of the SynchroMed II and SynchroMed EL infusion systems. This paper discusses the mechanism by which nonindicated drug formations can cause corrosion to the pumps internal components, resulting in permanent motor stalls and therapy cessation.
- SynchroMed EL Programmable Infusion System Clinical Reference Guide: Programming Module
This reference guide offers in-depth information on programming the SynchroMed EL Infusion System.
- SynchroMed EL Programmable Infusion System Clinical Reference Guide: Pump Refill Module
This reference guide provides information that is critical to the safe and accurate refill of the SynchroMed EL Infusion System.
- SynchroMed EL Programmable Infusion System Clinical Reference Guide: Troubleshooting
This reference guide is intended to be a reference for common troubleshooting procedures involving the Medtronic SynchroMed EL Infusion System.
- SynchroMed EL Programming Guide for Software Version B
SynchroMed EL programming guide for software application card model 8870 software version B.
- SynchroMed II and SynchroMed EL Priming Bolus Reference Card
This document outlines the priming bolus programming procedure.
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.
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 Therapy (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
