Guidant Recalls More Pacemakers
Following a two-week FDA inspection of its cardiac rhythm management manufacturing facility in St. Paul, MN, Guidant Corp. (Indianapolis) advised physicians and patients of two types of failures that have occurred in its Insignia and Nexus pacemaker models. The failures, although statistically rare, involved the sudden and intermittent or permanent loss of pacing ability, which resulted in serious heart-rhythm disturbances. No deaths were reported, but several patients experienced fainting, others required hospitalization for serious arrhythmias, and one had to be resuscitated following cardiac arrest.
Guidant reported that foreign material within a crystal timing component caused 36 failures out of 49,500 pacemaker units distributed worldwide, for a 0.073% rate of occurrence. Another type of failure occurred in 16 units of 341,000 shipped, for an even lower failure rate of 0.0047%. FDA classified Guidant’s advisory about the former type of failure as a recall, whereas there was some confusion about the second instance, which appears to remain as a safety alert. It is believed that both advisories will eventually be classified as recalls.
There have been no failures in products shipped after March 12, 2004, following a modification in the timing component by the supplier. Due to the rare occurrence of the failures, neither Guidant nor FDA has called for device removal. Both urge patient-doctor consultation to determine the most prudent course of action based upon the patient’s medical history and particular experience with the pacemaker. Surgical removal of the devices can be risky due to infection concerns. Guidant also recommends that the pacing function of the device be checked while it is still in the packaging and before implantation.
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Guidant’s McCoy: Finding the risk threshold. |
According to Fred McCoy, president of Guidant’s cardiac rhythm management division, the failures were noted in the company’s annual reports to FDA. He indicated that determining what risk threshold to use in disclosing problems remains a troublesome issue. Noting that the current failure rates were less than three-quarters of 1% in the first instance and less than one-half of 1% in the other, McCoy said, “One of the problems that any company in high-tech medical technology deals with is the low likelihood of failure. The decision about when to communicate actively is something we all struggle with.”
Approximately 170,000 pacemaker units are involved in the latest pacemaker recall and safety alert. Since June of this year, Guidant has recalled almost 200,000 pacemakers because of reported malfunctions. The company has also recalled more than 109,000 implantable cardioverter defibrillators (ICDs) during the same period. Whereas pacemakers use mild electrical currents to stimulate a slow heartbeat, ICDs—as well as external defibrillators—use a more powerful electrical jolt to correct life-threatening irregular heartbeats known as arrhythmias.
At the same time that Guidant was disclosing the problems with the two pacemakers, the company also advised physicians that two of its ICD units that were recalled on June 17—the Contak Renewal and Contak Renewal 2—were now linked to three deaths rather than the one fatality that was announced at the time of the initial recall.
Guidant has taken tremendous heat for the malfunctions in its pacemakers and ICDs, particularly after it became known that in some instances the company failed to disclose the failures to FDA, physicians, and patients in a timely manner, thereby exposing patients to unnecessary risks. Wave after wave of negative publicity about Guidant’s high-margin, signature cardiac rhythm management devices led many industry analysts to wonder if the disclosures would sink the company’s pending $25.4 billion acquisition by Johnson & Johnson Inc. (New Brunswick, NJ). That firestorm seems to have abated, but many still believe that the terms of the deal will be renegotiated.
Guidant’s woes are believed to be a key factor in recently increased regulatory and Congressional scrutiny of the medtech industry, and may also have contributed to the September 23 resignation of FDA Commissioner Lester M. Crawford, DVM, PhD.
But some industry analysts indicate that a failure rate of less than 1% in a sophisticated medtech device is hardly cause for an all-points recall. Without condoning poor device quality or failure to disclose device failures in a timely fashion, such analysts suggest that industry critics are overreaching, and that it may be time to inject a little balance and perspective into the discussion.
Medtech companies faced with matching their response to an appropriate risk threshold—including Guidant—might well appreciate such a change in the tone of current regulatory discussions. But whether critics will be willing to moderate their criticism is quite another question.
Canon Communications LLC
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