Medtronic Inc. is issuing a second recall of its SynchroMed II implantable pump used to deliver medication to patients with chronic pain, severe chronic pain and spasticity. It is also used to delivery medicine to treat primary or metastatic cancer. The recall stems from a possible battery issue which could affect drug delivery and signal the pump’s alarm. If that occurs, the pump will need to be replaced, often sooner than expected and/or the drug flow rate may need to be reset to a very low level. This can cause a return of underlying symptoms, and/or the possibility of drug withdrawal symptoms.

For example, patients receiving the drug intrathecal baclofen for severe spasticity are at risk for baclofen withdrawal syndrome, which can lead to a life-threatening condition if not treated quickly and effectively.

The SynchroMed II Implantable Programmable Drug Pump is part of the SynchroMed II Infusion system. The devices were recalled for the same battery issue in July 2009. Medtronic encourages patients to carry their patient identification cards with them at all times and to contact their doctors immediately if they experience a return of symptoms or hear a device alarm.

Medtronic is not retrieving any implanted SynchroMed II pumps from the field. Medtronic does not recommend prophylactic replacement of SynchroMed II pumps because of the estimated low occurrence rates, the presence of pump alarms, and the risks associated with replacement surgery.

Any side effects with this or any device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA