Medtronic says 13 deaths possibly related to Sprint Fidelis leads; Welch Allyn external defibrillators recalled

March 16, 2009

Minneapolis, MN - Medtronic believes its recalled Sprint Fidelis defibrillator leads "may have been a possible or likely contributing factor" to a total of 13 deaths, including four associated with extraction of the leads, according to a "Dear Doctor" letter from the company dated March 13, 2009 [1]. The numbers are based on a recent review of reports from the FDA MAUDE database by its independent physician quality panel, it said.

It is the first time since the company announced the Sprint Fidelis recall in October 2007 that Medtronic has updated the number of deaths possibly associated with failure of the leads. At the time, as reported by heartwire, Medtronic said the leads may have been involved in five deaths.

About 268 000 of the leads have been implanted, according to the company. It emphasizes, as it has from the beginning, that the risks of prophylactic Sprint Fidelis extraction likely exceed any risk associated with their failure, except in unusual cases.

Welch Allyn external defibrillators recalled

Skaneateles, NY - Welch Allyn has announced a recall of 14 054 of its model AED 10 and MRL JumpStart automatic external defibrillators manufactured between October 3, 2002 and January 25, 2007 and sold around the world [2,3]. The company has made the serial numbers of affected units available on its website.

"There is a remote chance that these devices may experience low energy shock, unexpected device shutdown, and/or susceptibility to electromagnetic noise interference.  If such issues arise, it may prevent defibrillation of a patient in cardiac arrest and could lead to death," according to the company. Because the chance of a malfunction is remote, it said, the devices should remain in use until they can be replaced.

Owners can contact Welch Allyn at 1-888-345-5356 or visit Welch Allyn for more information.


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