Voluntary Recall of Medtronic Implantable Defibrillators
Medical Devices Bulletin
For the Attention of Hospital CEOs, Chiefs of Staff, Chief Nursing Officers,
Bio-Medical Engineering Department Heads, Risk Managers and OHA Board of Directors
From Rosalind Smith, Vice President, Member & Professional Relations
Voluntary Recall of Medtronic Implantable Defibrillators
On February 11, 2005, Medtronic Inc. issued a press release advising health care providers about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models.
Medtronic reported that nine batteries (0.01 percent, or approximately 1 in 10,000) have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function.
Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Potentially affected models are the MarquisTM VR/DR and MaximoTM VR/DR ICDs and the InSync I/II/III MarquisTM and InSync III ProtectTM CRT-D devices.
While 75 percent of these devices were implanted in the United States, we are aware that some of these devices are in use in Ontario hospitals.
Medtronic indicates that patients with other models of Medtronic devices or these device models with batteries manufactured after December 2003 are not affected. To date, there have been are no reported patient injuries or deaths as a result of this issue.
Medtronic began notifying physicians about the situation on February 10, providing them with a list of potentially affected patients and recommending that physicians communicate with those patients and follow-up with them closely.
Health Canada is aware of this recall and will be posting a communication from Medtronic on their website shortly at: http://www.hc-sc.gc.ca under"More Advisories, Warnings and Recalls" under the heading, "Advisories for Health Professionals/Consumers". The direct URL is http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_advisories_e.html
Additional information about this potential issue is also available from Medtronic at 1-888-775-2702 or from their website www.medtronicinfo.com