Class 1 Recall of Medtronic SynchroMed Implantable Infusion System Devices

July 1, 2013

In June 2013, Medtronic, Inc. initiated four medical device notifications to customers worldwide about the SynchroMed Implantable Infusion System. The Food and Drug Administration (FDA) has classified three of these notifications as Class I recalls. The fourth notification is an update to a 2011 action related to pump refill which was previously classified by the FDA as a Class I recall.

Medtronic's intrathecal drug delivery systems are used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin.

The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Implantable Infusion Pumps) contain and administer prescribed drugs to a specific site inside the patient’s body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorph, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen. The SynchroMed pumps are used to treat primary or metastatic cancer, chronic pain, and severe spasticity. The implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories.

The Sutureless Connector Intrathecal Catheter and Revision Kits are accessories to an implanted infusion system designed to store and deliver parenteral drugs to the Intrathecal space. The implanted infusion system components consist of a Medtronic SynchroMed implantable drug infusion pump and an Intrathecal Catheter. The Sutureless Revision Kit is used when a pump connector for an Intrathecal Catheter is required.

These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System. Patients and caregivers should be aware of the signs and symptoms associated with intrathecal drug therapy complications and contact their physicians immediately if they hear a device alarm or experience symptoms of a drug overdose or underdose. Patients are encouraged to maintain regular follow-up appointments with their physicians; however, if they experience a change or return of symptoms or hear a device alarm, they should contact their physician immediately.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report online

    • Download form or call 1.800.332.1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1.800.FDA.0178

  • Read the MedWatch Safety Alert.


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