Medtronic implanted drug pump gets a second class I recall

August 30, 2011 by MassDevice staff

Medtronic's SynchroMed II implantable painkiller pump undergoes its second class 1 recall this year over reports of defective batteries.

SynchroMed II pain pump

Medtronic Inc.'s (NYSE:MDT) urgent update last month turned into a second class I recall for its SynchroMed II implantable drug infusion pumps over reports that the devices may have defective batteries that can lead to sudden failure.

The SynchroMed system includes an implanted catheter and pump infusion system that stores and delivers medication to a specific site. There are about 140,000 pumps in use worldwide.

Mid-July the Minneapolis, Minn.-based medical device giant issued an urgent warning that there had been 55 confirmed cases of battery defects resulting in device failure as of May 32, 2011. All but one report related to pumps with batteries manufactured prior to March 17, 2005.

The problem appeared to be the formation of a filmy substance within the pump battery that led the devices to shut down suddenly, causing a patient's pain and symptoms to return or triggering withdrawal symptoms.

"The FDA has approved a battery design change intended to prevent the issue from occurring in new pumps, and all SynchroMed II pumps are being manufactured with the new battery," Medtronic spokesperson Cindy Resman told MassDevice. "This design change has already been implemented in several global regions and is in the process of being implemented in the rest."

That brings the device to two class 1 recalls this year, the first issued in February over the potential for "pocket fills," which occur when drugs are unintentionally injected into the tissue where the pump is implanted rather than at the desired site.