Newly Released FDA Report Indicates Medtronic Had First Reports Of Lead Wire Problems In Late 2004
(Posted by Tom Lamb at DrugInjuryWatch.com)
A March 14, 2009 New York Times (NYT) article, "Medtronic Links Device for Heart to 13 Deaths", by reporter Barry Meier gave us the latest developments regarding the problems that gave rise to the October 2007 recall of Sprint Fidelis lead wires used in defibrillators.
Mr. Meier's March 14 NYT article was published a day after Medtronic sent a March 13, 2009 "Dear Doctor" letter, "Sprint Fidelis® Model 6949 Lead Performance". In that document, the medical device company states:
Approximately 268,000 Fidelis leads have been implanted worldwide. The FDA’s MAUDE database currently has 107 Medical Device Reports (MDRs) that include allegations that the Fidelis lead may have caused or contributed to a patient death. Most of these MDRs were not initiated by medical professionals; the majority were initiated by family members or attorneys with minimal supporting data. Medtronic’s Independent Physician Quality Panel has reviewed 89 of the 107 reports. It is not possible to determine cause of death with certainty.
The Panel has identified 13 patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. The Panel noted that four of the 13 deaths were associated with lead extraction, highlighting the risks associated with that procedure. With the exception of the appearance of deaths associated with lead extraction, no new or unexpected trends have been observed.
Building upon this March 2009 Sprint Fidelis "Dear Doctor" letter, Mr. Meier adds some contextual information:
The death statistics Medtronic released [March 13] underscore both the scope of the Sprint Fidelis problem and the difficult choices that doctors and patients face in deciding what to do about it. About 150,000 people in this country still have the Sprint Fidelis leads in their bodies.
Along with fatalities, the F.D.A. has received about 2,200 reports of serious injuries related to the leads. Medtronic officials said they believed that reflected the number of people who had undergone surgery to have a failed lead replaced with a new one.
But the larger part of Mr. Meier's March 14 article has to do with a "new" FDA report that was provided to this NYT reporter by lawyers involved with product liability lawsuits concerning serious injury or death caused by the defective Sprint Fidelis lead wires. Here is how Mr. Meier describes that FDA report:
[A] previously undisclosed Food and Drug Administration report indicates that Medtronic began receiving reports soon after the device reached the market in late 2004 that the cable, known as the Sprint Fidelis, was fracturing....
The F.D.A. report is based on a visit by regulators to a Medtronic facility in Mounds View, Minn., soon after the device was removed from the market, where the officials interviewed executives and inspected records.
The report shows that by late 2005 the company had received 30 complaints about device fractures and had identified several possible ways in which the lead might be failing. About that time, the company opened an internal investigation into the problem, according to the report.
What happened next is not clear, because the F.D.A. redacted portions of the report before releasing it. But the document indicates that Medtronic engineers met often about the problem throughout 2006 and that they performed a “statistical analysis of the three failure modes” of the lead in October of that year, the report states.
This FDA report is significant as regards some critical issues in any Sprint Fidelis lawsuit filed against Medtronic, specifically: (1) When did Medtronic first learn about the potentially fatal failures involving its Sprint Fidelis lead wire products; and, (2) What did Medtronic do about these Sprint Fidelis failure reports from that point time up until when the company finally issued its October 2007 Sprint Fidelis recall?
We will continue to provide updates on this Sprint Fidelis recall and the thousands of related legal claims.