Important Safety Information Drug Delivery Systems for Severe Spasticity

SynchroMed^™ II Drug Infusion System Brief Statement:

Review product technical manuals, including information about EMI, and the appropriate drug labeling prior to use for detailed disclosure.

Indications

 US: Chronic intrathecal infusion of Infumorph^® preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Prialt^® 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. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling.

Drug Information

Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration, screening procedures, and under-/overdose symptoms and methods of management. Patients should be informed of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions, and signs and symptoms that require medical attention.

Contraindications

System implant is contraindicated in the presence of an infection; implant depth greater than 2.5 cm below skin; insufficient body size; and spinal anomalies. Use of the system with drugs with preservatives and drug formulations with pH ≤3. Use of CAP kit for refills or of refill kit for catheter access and use of PTM to administer opioid to opioid-naïve patients.

Warnings

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. 

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 carefully for any new neurological signs or symptoms, change in underlying symptoms, or need for rapid dose escalation. Monitor patients appropriately after refill if a pocket fill is suspected. Failure to recognize signs and symptoms of pocket fill and seek appropriate medical intervention can result in serious injury or death. Overinfusion may lead to underdose or overdose symptoms. Strong sources of electromagnetic interference (EMI) 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. The SynchroMed II system is MR Conditional; consult the labeling for MRI information.

Precautions

Monitor patients after pump or catheter replacement for signs of underdose/overdose. Infuse preservative-free saline at minimum flow rate if therapy is discontinued for an extended period to avoid system damage. EMI may interfere with programmer telemetry during pump programming sessions. 

Adverse Events

 In addition to procedure-related risks, the following may occur: pocket seroma; hematoma; erosion; infection; pump inversion; pump migration; post-lumbar puncture risks (spinal headache); CSF leak and rare central nervous system pressure-related problems; radiculitis; arachnoiditis; spinal cord bleeding/damage; meningitis; neurological impairment (including paralysis) due to inflammatory mass; allergic response to implant materials; surgical replacement due to end of service life or component failure; loss of therapy, drug overdose, or inability to program the pump due to component failure; catheter complications resulting in tissue damage or loss of or change in therapy; potential serious adverse effects from catheter fragments in intrathecal space.

For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com

Infumorph^® is a registered trademark of Hikma Pharmaceuticals USA Inc. Prialt^® is a registered trademark of TerSera Therapeutics LLC. Lioresal^® is a registered trademark of Saol.

USA Rx Only

Rev 1120