Medtronic Fidelis Sprint Lead Failures: Did The FDA Wait Too Long To Issue Its October 2007 Recall

A Significant Increase In Number of Patient Injury And Adverse Event Reports During First Part Of 2007 Should Have Been Safety Signal Says Public Citizen

On October 15, 2007 the FDA issue its "Class 1 Recall: Medtronic Inc. Sprint Fidelis® Defibrillator Leads" which included this information:

• Product: Medtronic Inc. Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007.
• Use: Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that are used to treat abnormal heart rhythms that can cause the heart to stop suddenly.
• Reason for Recall: These leads are being recalled because a small number of “fractures” have been detected. When the lead breaks or fractures, it may send false signals that cause inappropriate shocks or therapies such as pacing or shocks may not be delivered.

The next day, the consumer advocacy group Public Citizen sent a letter to the FDA which posed this question: "Why did the FDA, aware of the rapidly mounting number of injury reports, not force the company to recall defibrillators not yet implanted in the early part of the year?"

An October 16, 2007 article written by reporter Kim Dixon for Reuters provides more details:

Patient injury reports for the tiny wires used with Medtronic's implantable heart devices jumped dramatically in the past year, a consumer group said on Tuesday, a day after the wires were recalled for possible links to five deaths.

U.S. health regulators received reports of 1,194 patient injuries in the first 10 months of 2007, compared with 296 in the same period in 2006, the consumer group Public Citizen said, citing U.S. Food and Drug Administration data.

The jump in numbers of patient injuries, and an even greater increase in reports of inappropriate patient shock, was apparent in the first few months of 2007, the group said.

Now that it has come to light that Sprint Fidelis leads used in defibrillators made by Medtronics, Boston Scientific, Guidant, and St. Jude can fracture and malfunction, it seems certain their will be a Congressional investigation to focus on the FDA oversight of medical devices -- which are regulated under different standards than those that pertain to prescription drugs. In fact, Senator Chuck Grassley, a Republican from Iowa, had already indicated that he was on this mission the day after this Medtronic recall.

Insofar that a defective Sprint Fidelis heart lead / defibrillator wire can cause these implanted heart devices to send a harmful unnecessary electrical shock or, even worse, to fail to transmit a life-saving shock to the patient's heart when needed, such an investigation of what the FDA (and Medtronic) knew and when they knew it is certainly warranted. One area of focus, no doubt, will be what transpired between the time when Medtronic sent its little noticed March 2007 "Dear Doctor" letter about problems with the Fidelis Sprint defibrillator wires and the October 2007 FDA recall.