Class I Recall Issued for Medtronic Drug Pump

Medtronic Model 8637 SynchroMed II Implantable Infusion Pumps are being recalled in what the U.S. Food and Drug Administration (FDA) is classifying as a Class I recall, its most serious and which involve situations in which there is a reasonable probability that use of the recalled device will cause serious adverse health consequences or death.

The recalled SynchroMed II Implantable Infusion Pump, models 8637-20 and 8637-40, were distributed between May 2004 and July 8, 2011. Medronic has set up a Device Identification web page where customers can enter the serial number for their SynchroMed II infusion pump to determine if their pump is involved in the recall. The page can be accessed here.

The SynchroMed II Implantable Programmable Drug Pump is part of the SynchroMed II Infusion system that was designed to contain and administer prescribed drugs to a specific site. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes.

In the United States, the SynchroMed II Pump is used on patients in which the chronic infusion of drugs or fluids is called for. This infusion pump is used for the delivery of morphine sulfate, ziconotide, and baclofen for the treatment of chronic pain, severe chronic pain, and severe spasticity, respectively. The device is also used to deliver floxuridine and methotrexate to treat primary or metastatic cancer.

As we’ve previously written, there is a potential for reduced battery performance in the SynchroMed II infusion Pump. Medtronic’s analysis of the problem indicates the problem is related to the formation of a film within the pump battery, which can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms. For example, said the FDA, patients receiving intrathecal baclofen therapy for severe spasticity are at risk for baclofen withdrawal syndrome. This can lead to a life-threatening condition when not treated appropriately and in time. SynchroMed II infusion pumps were recalled for the same battery issue in July 2009.

Medtronic encourages patients to carry their patient identification cards with them at all times, immediately contacting their physicians if a return of symptoms occurs or a device alarm is set off.

The recall was initiated by Medtronic, Inc.–Neuromodulation, located at 7000 Central Ave NE; 
Minneapolis; Minnesota; 55432-3568. Medtronic Patient Services can be reached, toll-free, at 1.800.510.6735, Monday through Friday, 8:00 a.m. to 5:00 p.m., Central Daylight Time (CDT). Healthcare providers are advised to contact their Medtronic field representative, or Medtronic Neuromodulation Technical Services at 1.800.707.0933.

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

In July, Medtronic wrote to physicians about potential reduced battery problems with its SynchroMed II Implantable Drug Infusion Pumps. We reported at the time that, as of the end of May, 55 confirmed cases of battery reduction problems were received globally. About 139,653 devices have been implanted around the world. Medtronic first issued a warning in July 2009 for the devices. That warning was classified as a Class II by the FDA, not its most serious, but a significant warning in that the device could cause temporary health problems or a slight risk of a serious nature. At the time, a Medtronic spokeswoman said the company was working with the FDA on a design change for the device.

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