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(Sept. 2011) A Battery Design Fault Leads to a Recall by Medtronic

 A Class I recall by the FDA   on Medtronic’s SynchroMed ll (an implantable pump which delivers drugs) was announced on September 12, 2011. A malfunction caused by a film formation on the pump’s  battery caused the pump to stop therapy.  Such problems were not noted until 45 to 78 months after the pumps had been implanted.  

 Models  8637-20 and 8637-40 could  be defective because of the batteries.  Physicians have been alerted. 

  Medtronic received FDA approval for a new battery design in July for the pumps.   Shipment of new units has already begun.

 References:      “Medtronic SynchroMedII Infusion Pump Warning: Battery Failures Reported, 07/12/2011, http://www.aboutlawsuits.com/medtronic-synchromed-battery-probl…

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm271510.htm

Ed. Note: The battery type not specified in Medtronic literature. It is highly likely that it employs Lithium Silver oxide + vanadium pentoxide.