SynchroMed II Drug Infusion Pump
Intrathecal Baclofen Therapy with Lioresal Intrathecal (baclofen injection)
Intrathecal Baclofen Therapy with Lioresal Intrathecal (baclofen injection)
The Medtronic SynchroMed™ II pump is part of the SynchroMed II programmable drug infusion system which provides precise drug delivery for chronic therapy for severe spasticity. In addition to the implanted pump, the SynchroMed II infusion system uses a catheter to deliver programmed amounts of Lioresal® Intrathecal (baclofen injection) (a muscle relaxant and antispasticity agent) directly to the intrathecal space and cerebrospinal fluid. The pump and catheter are implanted under the skin.
Infusion dosing must be precise, consistent, reliable — day to day and over the life of the drug delivery system. Even small variances from a patient's dosing can have significant impact on clinical outcomes, side effect profiles, and patient satisfaction.
The SynchroMed II infusion system delivers documented precision and optimal performance. Annual product performance reports share data from a prospective, long-term multi-center registry.
Flex dosing patterns allow drug delivery to be matched to patient needs, providing optimal relief for predictable fluctuations in spasticity throughout the day
Smart software guides the clinician through programming the system, via information and warning screens.
Critical therapy and patient data stored in the pump allow flexibility for follow-up at other institutions
The drug enters the pump through the reservoir fill port and passes through the reservoir valve and into the SynchroMed II pump reservoir. At normal body temperatures, pressurized gas that is stored below the reservoir expands, exerting constant pressure on the reservoir. This pressure advances the drug into the SynchroMed II pump tubing. The battery-powered electronics and motor precisely push the programmed dose out through the catheter port and into the catheter.
The peristaltic action of the SynchroMed II pump moves the drug from the pump reservoir, through the pump tubing, check valve, catheter port, and implanted catheter, to the infusion site.
The catheter access port (CAP) allows injection of the drug directly into the implanted catheter for drug administration and diagnostic purposes. Drug injected into the CAP bypasses the SynchroMed II pump mechanism and goes directly through the catheter port into the implanted catheter to the infusion site.
The SynchroMed II pump has suture loops for anchoring the pump in the pocket.
The SynchroMed II programmable pump is noninvasively controlled by the handheld N'Vision clinician programmer, equipped with an intuitive touchscreen and user-friendly software. The pump can deliver medication at either a constant rate or a variable rate, as deemed therapeutically appropriate by the managing physician.
Studies indicate that programmability may help address fluctuations that accompany severe spasticity.1,2
Flex dosing may improve ITB TherapySM results in patients who:1,4
Changing from simple continuous dosing to flex dosing in ITB Therapy patients may:2
Implanting the SynchroMed II infusion pump under the appropriate conditions will not restrict patients from receiving a full body MRI scan. The SynchroMed II infusion system allows safe full-body access to 1.5 and 3.0-Tesla MRI.* The pump is designed to resume programmed therapy after the scan.**
* Under specific conditions. Refer to product labeling for the full list of conditions.
** Requires interrogation to confirm pump status.
Access prescriber, implant, MRI, and other manuals on the Medtronic Manual Library Search by the product name (SynchroMed) or model number (8637). You may also call 800-961-9055 for a copy of a manual.
|Model||8637-20 (20 mL reservoir)||8637-40 (40 mL reservoir)|
|Battery Life||4 to 7 years||4 to 7 years|
|Weight (empty/full)||165/185 g (5.8/6.5 oz)||175/215 g (6.2/7.6 oz)|
|Thickness||19.5 mm (0.78 in)||26 mm (1.0 in)|
|Minimum flow rate||0.048 mL/day||0.048 mL/day|
For additional information please refer to SynchroMed II Brief Statement and Lioresal prescribing information.
Rainov NG, Buscher E. Making a case for programmable pumps over fixed rate pumps for the management of fluctuations in chronic pain and spasticity: a literature review. Neuromodulation. 2002;5:89-99.
Krach LE, Kriel RL, Nugent AC. Complex dosing schedules for continuous intrathecal baclofen infusion. Pediatr Neurol. 2007;37:354-359.
Global Markets for Magnetic Resonance Imaging Systems. Millennium Research Group, 2009.
Natale M, Mirone G, Rotondo M, Moraci A. Intrathecal baclofen therapy for severe spasticity: Analysis on a series of 112 consecutive patients and future prospectives. Clin Neurol Neurosurg. 2012;114(4):321-325.
Product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed disclosure.
US: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity; chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling.
Infection; implant depth greater than 2.5 cm below skin; insufficient body size; spinal anomalies; drugs with preservatives, drug contraindications, drug formulations with pH ≤3, use of catheter access port (CAP) kit for refills or of refill kit for catheter access, blood sampling through CAP in vascular applications, use of Personal Therapy Manager to administer opioid to opioid-naïve patients or to administer ziconotide.
Non-indicated formulations may contain neurotoxic preservatives, antimicrobials, or antioxidants, or may be incompatible with and damage the system. Failure to comply with all product instructions, including use of drugs or fluids not indicated for use with system, or of questionable sterility or quality, or use of non-Medtronic components or inappropriate kits, can result in improper use, technical errors, increased risks to patient, tissue damage, damage to the system requiring revision or replacement, and/or change in therapy, and may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug under- or overdose. Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration, screening procedures and underdose and overdose symptoms and methods of management. Physicians must be familiar with the drug stability information in the product technical manuals and must understand the dose relationship to drug concentration and pump flow rate before prescribing pump infusion. Implantation and ongoing system management must be performed by individuals trained in the operation and handling of the infusion system. An inflammatory mass that can result in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms, change in underlying symptoms, or need for rapid dose escalation.
Inform patients of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical attention, including prodromal signs and symptoms of inflammatory mass. If it is suspected or known that all or part of the drug was injected into the pocket during the refill procedure, monitor the patient closely for signs and symptoms of overdose in an appropriate facility for a sufficient amount of time or until the symptoms have resolved. Failure to recognize signs and symptoms and seek appropriate medical intervention can result in serious injury or death. Instruct patients to notify their healthcare professionals of the implanted pump before medical tests/procedures, to return for refills at prescribed times, to carry their Medtronic device identification card, to avoid manipulating the pump through the skin, to consult with their clinician if the pump alarms and before traveling or engaging in activities that can stress the infusion system or involve pressure or temperature changes. Strong sources of electromagnetic interference (EMI), such as short wave (RF) diathermy and MRI, can negatively interact with the pump and cause heating of the implanted pump, system damage, or changes in pump operation or flow rate, that can result in patient injury from tissue heating, additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose. Avoid using shortwave (RF) diathermy within 30 cm of the pump or catheter. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. Drug infusion is suspended during MRI; for patients who can not safely tolerate suspension, use alternative drug delivery method during MRI. Patients receiving intrathecal baclofen therapy are at higher risk for adverse events, as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively. Confirm pump status before and after MRI. Reference product labeling for information on sources of EMI, effects on patient and system, and steps to reduce risks from EMI.
Monitor patients after device or catheter replacement for signs of underdose/overdose. Infuse preservative-free (intraspinal) saline or, for vascular applications, infuse heparinized solutions therapy at minimum flow rate if therapy is discontinued for an extended period of time to avoid system damage. EMI may interfere with programmer telemetry during pump programming sessions. EMI from the SynchroMed programmer may interfere with other active implanted devices (e.g., pacemaker, defibrillator, neurostimulator).
Include, but are not limited to, spinal/vascular procedure risks; infection; bleeding; tissue damage, damage to the system or loss of, or change in, therapy that may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose, due to end of device service life, failure of the catheter, pump or other system component, pump inversion, technical/programming errors, injection into the pocket or subcutaneous tissue or improper use, including use of non-indicated formulations and/or not using drugs or system in accordance with labeling; pocket seroma, hematoma, erosion, infection; post-lumbar puncture (spinal headache); CSF leak and rare central nervous system pressure-related problems; hygroma; radiculitis; arachnoiditis; spinal cord bleeding/damage; meningitis; neurological impairment (including paralysis) due to inflammatory mass; potential serious adverse effects from catheter fragments in intrathecal space, including potential to compromise antibiotic effectiveness for CSF infection; anesthesia complications; body rejection phenomena; local and systemic drug toxicity and related side effects; potential serious adverse effects from catheter placement in intravascular applications.
Lioresal® is a registered trademark of Saol
USA Rx Only
Important Safety Information
Indications and Usage
Select Warnings and Precautions
Common Adverse Reactions
Serious Adverse Reactions
Use in Specific Populations
For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.