Medtronic’s SynchroMed II implantable painkiller pump has been recalled. This is the second class 1 recall this year due to reports of defective batteries. Medtronic’s urgent update last month became a second class I recall for its SynchroMed II implantable drug infusion pumps because of 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. There have now been 55 confirmed cases of battery defects resulting in device failure as of May 31, 2011.
The problem is caused by 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 and the design change has already been implemented in several global regions and is in the process of being implemented in the rest.
Class 1 recalls are considered the most serious type of recall, reserved for situations with a reasonable probability of serious adverse consequences or death.