Medtronic has sent a letter to doctors with additional information about the potential for reduced battery performance in a small percentage of its SynchroMed II implantable drug infusion pumps used to treat pain. The devicemaker first disclosed this issue in a July 2009 letter to physicians. Medtronic isn't recalling the product from the field or recommending surgical removal unless a patient's pump demonstrates reduced battery performance.
So far, there have been 55 confirmed cases of this issue from the roughly 139,653 SynchroMed II pump implants worldwide. The pump was designed to last up to 84 months, and these events occurred between 45 and 78 months after implant, the company says in a statement. All but one of the cases occurred in pumps with batteries manufactured prior to March 17, 2005.
A company analysis indicates the issue is related to the formation of a film within the pump battery that may impact performance, leading to the loss of therapy and return of underlying symptoms as well as withdrawal. Medtronic is urging patients to carry their identification cards at all times and to contact their physicians immediately if they experience a return of symptoms or hear a device alarm.
Medtronic says it is working to obtain U.S. approval for a battery design change intended to prevent the issue from occurring in the future. The design change has been implemented in Europe, Australia, New Zealand, Canada, Africa and India.
- see the Medtronic statement