Heart Device Wire Recommendations Issued

June 04 2009 UPDATE –The Heart Rhythm Society, which represents doctors who implant and extract heart devices, has issued recommendations aimed at improving patient safety. The group's recommendations come two months after Medtronic confirmed that at least 13 deaths may be linked to their defibrillator "leads," or wires, and that four of the deaths happened during surgical extractions of the leads.

The group wrote new guidelines for the industry, insisting that every lead put on the market be monitored before problems arise. In addition, they urged the Food and Drug Administration (FDA) to establish rules for how much manufacturers can alter products and still use laboratory testing, instead of human clinical trials, to gain FDA approval.

A separate panel recommended that doctors who perform lead extractions set up a registry to disclose the outcomes of their surgeries. This would provide a record of whether devices were successfully removed without causing harm to the patient.

Medtronic Heart Devices Linked to 13 Deaths

March 2009 ORIGINAL ALERT – Medtronic Inc. has confirmed that at least 13 people may have died in connection with heart devices that the company recalled in 2007. When the recall was first issued, Medtronic cited five patient deaths, and this is the first update since that time.

The devices are thin electrical cables called "leads" that connect an implanted defibrillator to a patient's heart. The leads go by the brand name Sprint Fidelis and are meant to carry electrical jolts to the heart and correct irregular heartbeats. At the time of the original recall, Medtronic said fractures in the cables could cause a defibrillator to fail to deliver a lifesaving shock or to fire for no reason. In addition, it has been found that four of the 13 deaths resulted from attempted surgical extractions of the device.

Approximately 268,000 Sprint Fidelis leads have been implanted in patients around the world. Medtronic said it has received 107 reports that the Fidelis may have been a factor in a patient death but that an independent doctors panel has reviewed 89 of the reports and found "minimal supporting data."