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.
"A pocket fill can cause life threatening injuries or death due to overdose or underdose of the drug," according to the company’s February press release. Medtronic updated the product’s labeling to provide more detail on needle placement for the device.
The battery problem arose even earlier, first noted in a July 2009 letter to physicians. Medtronic provided an update last month with no recall planned and recommending the devices not be surgically removed unless there were battery issues observed.
A class 1 recall was issued yesterday as an update to previous warnings. Patients were instructed to call the firm for further instructions.
Class 1 recalls are considered the most serious type of recall, reserved for situations with a reasonable probability of serious adverse consequences or death.