SynchroMed II Drug Infusion System

Implant Procedure & Techniques

Screening Test

Adverse events from the screening test may include hypotonia, somnolence, headache, dizziness and nausea/vomiting.

Before implantation, a screening test of Lioresal® (baclofen injection) is necessary to assess the patient's response to the medication.

 

 

The screening test must be conducted in a medically supervised and adequately equipped environment with immediate access to resuscitative equipment.

Prior to the screening test, be sure to do the following:

  • Educate patient and caregiver regarding the screening test procedure
  • Consider titration or discontinuation of concomitant oral antispasmodic medications; some physicians only hold the daily dose on the day of screening
  • Prepare for the possibility of significant hypotonia during screening as a result of the bolus injection

Single Injection

The patient is injected with a single bolus injection of intrathecal baclofen, via a lumbar puncture.

  • The dose is typically 50 mg per day

Refer to the drug package insert for procedure and dosing recommendations and a complete listing of warnings, precautions, and contraindications. For pediatric patients, also refer to the drug package insert.

Implant Procedure

The Medtronic SynchroMed® II Programmable Infusion System (including a Medtronic intrathecal catheter) is implanted in a sterile surgical procedure performed under general or regional anesthesia.

The SynchroMed II pump is typically implanted in the lower abdomen just beneath the skin. One end of the catheter is inserted into the intrathecal space of the spine. The other end of the catheter is then tunneled under the skin and connected to the pump.

Contraindications for Pump Implant

Implantation of the programmable pump is contraindicated:

  • In the presence of infection
  • When the pump cannot be implanted 2.5 cm or less from the surface of the skin
  • In patients whose body size is not sufficient to accept the pump bulk and weight

Contraindications relating to the use of the prescribed drug must be observed. For ITB Therapy (Intrathecal Baclofen Therapy) , hypersensitivity to oral baclofen is contraindicated.

For more information, see Indications, Safety & Warnings.

Refer to the drug package insert for procedure and dosing recommendations and a complete listing of warnings, precautions, and contraindications. For pediatric patients, also refer to the drug package insert.

Procedure Videos

This short video contains an overview of the bridge bolus programming procedure.

This video gives an overview of pump preparation prior to implant including supplies, pump package contents, confirming pump status, sterile field, emptying the pump and more.

This video shows how to connect the syringe and empty the pump prior to a refill.

This video shows how to prepare and assemble the syringe and illustrates a pump refill.

This video shows how to rinse the SynchroMed II pump.

This video provides in-depth information on the refill procedure for the SynchroMed II and SynchroMed EL infusion systems.

Refer to the drug package insert for procedure and dosing recommendations and a complete listing of warnings, precautions, and contraindications. For pediatric patients, also refer to the drug package insert.

 

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