Medtronic SynchroMed Implantable Infusion System Devices: Class 1 Recalls - Feed Through Failure, Failure of Priming Bolus, and Catheter Occlusion

Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps – Failure of Priming Bolus

• Reason for Recall: The SynchroMed Implantable Infusion Pumps are being recalled because of the unintended delivery of drugs during the priming bolus procedure. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid (CSF) followed by a period of reduced drug delivery after the priming bolus. This can result in a drug overdose or under dose which can lead to serious medical illness such as respiratory depression, coma or death.
• Products: SynchroMed II, Model 8637 (20 ml or 40 ml reservoir size)
  SynchroMed EL Programmable Pumps, Models 8626, 8626L, 8627, 8627L (10 ml or 18 ml reservoir size).
• Medtronic recommends healthcare professionals continue using the priming bolus procedure to ensure therapy is initiated while a patient is under medical supervision. For Complete list of recommendations please see Class 1 Recall Notice.

Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps – Feed Through Failure

• Reason for Recall: There is a potential for electrical shorting, internal to the SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and may lead to a loss of or reduction in therapy. This may result in the return of underlying symptoms and/or withdrawal symptoms. Use of this recalled product may result in serious adverse health consequences, including death.
• Products: SynchroMed II, Model 8637 (20 ml or 40 ml reservoir size)
  SynchroMed EL Programmable Pumps, Models 8626, 8626L, 8627, 8627L (10 ml or 18 ml reservoir size).

 Medtronic Sutureless Connector Intrathecal Catheter Products – Catheter Occlusion

• Reason for Recall: The Sutureless Connector Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion, which is the blockage or stoppage of drug flow due to misalignment at the point where the catheter connects to an implantable pump. Medtronic is removing all unused products that were manufactured with the previous design. Medtronic recommends the previous design of Sutureless Connector Intrathecal Catheter Products no longer be used due to greater potential for misalignment and subsequent occlusion. This product may cause serious adverse health consequences, including drug under dose, loss of symptom relief, drug withdrawal symptoms caused by the lack of drug delivery to the Intrathecal space, and/or death.
• Products: Sutureless Connector Intrathecal Catheters, Models 8709SC, 8731SC
  Sutureless Revision Kits, Models 8596SC, 8578
• Medtronic does not recommend the use of any affected devices with the old design.

SynchroMed Implantable Infusion Pump Refill Procedure Safety Update

• Medtronic is distributing a revised Clinician Refill Reference Card with information about the pump refill procedure for the SynchroMed Implantable Infusion System. This is a continuation of a 2011 notification that was previously classified as a Class I recall. The revised reference card reflects new product labeling approved by the FDA to help healthcare professionals reduce the potential for a pocket fill during the SynchroMed pump refill procedure. A pocket fill is the inadvertent injection during a refill procedure of all or some of the prescribed drug into the patient's subcutaneous tissue, which includes the pump pocket (area under the skin where the pump is placed), instead of into the pump.