Medtronic has issued an urgent medical device correction on its SynchroMed II implantable drug infusion pumps, warning that the batteries in certain devices might suddenly fail, according to a news release by Medtronic.
Medtronic does not plan on recalling the pumps at this time and does not recommend surgical removal unless the device has poor battery performance. Apparently, a filmy substance forms within the pump battery, causing a sudden shutdown.
By May 31, there were 55 confirmed cases of device failures, with all but one involving batteries made before March 17, 2005. The issue was first reported in July 2009, and the FDA labeled it a class II action, denoting a problem that might cause temporary health problems or a slight threat of a serious nature.
Read the Medtronic release on the SynchroMed II.
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