Manuals and Technical Resources
This document includes information about contraindications, adverse events, component disposal, and other information regarding Medtronic SynchroMed® and IsoMed® infusion systems.
This is the package insert for Lioresal® Intrathecal (baclofen injection).
This manual provides instructions for using for the SynchroMed II programmable infusion system model 8637.
This is the instructions-for-use manual for the catheter access ports kits for use with the Medtronic SynchroMed II pump.
This technical manual includes the instructions for using the Ascenda® intrathecal catheter model 8780.
This technical manual includes the instructions for using the Ascenda intrathecal catheter model 8781.
This implant manual provides instructions for using the InDura catheter model 8711.
This implant manual includes the instructions for using the intrathecal catheter and sutureless connector model 8731SC.
This manual provides instructions for using the revision kit model 8596SC when a revision to the pump segment of the intrathecal catheter model 8731 or model 8731 is required.
This manual provides instructions for using the intrathecal catheter distal revision kit model 8598A to replace parts for the spinal section of intrathecal catheters model 8731 and model 8731SC.
This manual provides instructions for using the sutureless pump connector revision kit model 8578 for intrathecal catheters model 8709 and model 8709SC.
This reference manual contains information specifically regarding indications, drug stability, and emergency procedures for the SynchroMed and IsoMed infusion systems.
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.
This programming guide provides SynchroMed II pump model 8637 programming instructions for the software application card model 8870 software version B, using the N'Vision clinician programmer.
This manual provides information for patients about the SynchroMed II infusion system.
This guide provides an overview of an Ascenda intrathecal catheter implant procedure for intrathecal drug delivery.
This guide provides an detailed overview of programming the SynchroMed II programmable infusion system with the N'Vision clinician programmer.
This card provides supplemental instructions for refilling Medtronic SynchroMed pumps. Topics include locating and palpating the pump, inserting the needle, emptying the pump, and refilling the pump.
The Critical Actions in the Pump Refill Procedure card supplements the Instructions for Use manuals included with the Medtronic SynchroMed Implantable Infusion Pump refill kits. It should be used in conjunction with these manuals and the Clinical Reference Guide.
At each Lioresal Intrathecal (baclofen injection) refill, clinicians can give patients a SynchroMed Refill Appointment Card. The card provides patients with the date of their next refill appointment and a list of overdose/underdose symptoms to watch for following a refill.
Emergency procedure information for underdose and overdose of Lioresal Intrathecal (baclofen injection).
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.
The seven chapters of the SynchroMed Programmable Infusion Systems Clinical Reference Guide offer in-depth information on various aspects of this programmable pump, used for the management of chronic pain and severe spasticity. The chapters include Intrathecal Morphine for Intractable Chronic Pain Management, Intrathecal Baclofen Therapy for Severe Spasticity Management, Surgical Procedures, Therapy Maintenance, Programming, System Components, and myPTM Personal Therapy Manager.
ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. 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.
Important Safety Information 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). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information.
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 (800) 328-0810.
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