Medtronic lead recall could have come earlier
Since the October 15th Medtronic recall for all models of their Sprint Fidelis defibrillator lead, more information has come to light about what Medtronic knew and when they knew it. Despite information which was presented to company executives, Medtronic delayed the defibrillator lead recall for several months, allowing doctors to continue implanting the defective wires.
>>INFORMATION: Medtronic Lead Recall
An article in the Wall Street Journal earlier this week outlined steps that were taken by physicians at the Minneapolis Heart Institute, who identified problems with the Medtronic defibrillator lead at the beginning of this year. Despite reports which indicated that the Sprint Fidelis lead was prone to early fractures, Medtronic did not issue a recall and at one point even attempted to shift the blame to the physicians who implant the devices. Below is a timeline of the events leading up to the recent Medtronic recall, as reported by the Wall Street Journal.
MEDTRONIC RECALL TIMELINE
September 2004: The Medtronic Sprint Fidelis defibrillator lead was introduced as the thinnest wire available, with a diameter of 2.2 millimeters. This made for easier insertion of the lead through the vein which connects the defibrillator to the heart.
January 2007: Doctors at the Minneapolis Heart Institute had two patients come into the clinic on successive days complaining that their heart defibrilator had delivered painful and unnecessary electrical shocks. A subsequent search of hospital records by physicians at the Heart Institute found four similar cases, and it was determined that all six patients had a broken Medtronic Sprint Fidelis defibrillator lead. The Minneapolis Heart Institute notified Medtronic about their concerns.
February 2007: A Medtronic vice president and engineer met with physicians from the Minneapolis Heart Institute and Dr. Robert Hauser, a physician who is well known for his role in the discovery of problems which led to the recall of over 200,000 Guidant defibrillators and pacemakers in 2005. Althought Dr. Hauser and physicians from the Heart Institute told Medtronic that they had a serious lead problem on their hands, executives from the device manufacturer claimed that there was not enough evidence and suggested that doctor error when the leads were implanted could have caused the fractures.
March 21, 2007: Medtronic sent a letter to healthcare providers indicating that they had received reports of fractures from a limited number of physicians who implant the leads. The letter attempted to reassure healthcare providers that the Medtronic lead was safe, and indicated that the problems may be caused by improper handling by the doctors during the implant procedure.
April 2007: Dr. Hauser published a report online in the medical journal Heart Rhythm, which concluded that the Medtronic lead “appears to be prone to early failure.” The report was based on an analysis of a federal database and of records from a multi-hospital database.
July 19, 2007: Dr. Hauser and physicians from the Minneapolis Heart Institute met with Medtronic executives again to ask them to issue a defibrillator lead recall. Medtronic indicated that they were not going to issue a recall, and that they were working to resolve the defibrillator lead problem which the company had already identified.
October 7, 2007: After reviewing the results of their own analysis of data collected since 2004 which indicated the Sprint Fidelis had a failure rate of approximately 2.3% during the first 30 months it was on the market, executives at Medtronic met and decided that the company would suspend sales of their popular leads.
October 15, 2007: A press release was issued shortly after midnight announcing the Medtronic recall. The company cited at least five deaths linked to their lead and acknowledged that their own analysis of data found that the failure rate was over two and a half times that of the older, thicker Medtronic lead, the Sprint Quattro.
MEDTRONIC LEAD RECALL LAWYERS
The lawyers at Saiontz & Kirk, P.A. are reviewing potential Medtronic recall lawsuits nationwide. Any individuals who have the Medtronic Sprint Fidelis lead may be at risk for serious injury if the lead fractures or fails. Claims are being reviewed for any heart patients who have had a defibrillator implanted since 2004. To determine if you, a friend or family member may be eligible for a claim, request a free consultation.
