Two years after Medtronic recalled its Sprint Fidelis defibrillators, new data shows the problems were more widespread than previously feared.
A recent study shows the electrical cables or “leads” used in the defibrillators may be failing even more often than previously known. More than 235,000 of the defective leads were implanted in unsuspecting patients before the recall was announced. Unfortunately, many of those patients still have the devices in their bodies.
Two imminent physicians, Dr. Robert Hauser of the Minneapolis Heart Institute and Dr. Douglas Hayes of the Mayo Clinic studied the data from 3,000 patients, and reported that only 88% of the implanted leads were still functioning. The doctors warned that the hazard of failure of the Sprint Fidelis lead was increasing. The manufacturer, Medtronic, had previously claimed 95% were still functional and cannot explain the discrepancy in the failure rate findings.
The very real problem this presents to both patients and doctors is whether to risk surgery to remove the defective lead, which, in some situations, has caused death.
Last month a federal judge dismissed all claims against Medtronic citing the U.S. Supreme Court’s Riegel decision which shielded manufacturers from liability if the device had been approved by the FDA.
We must urge all concerned patients to contact their legislators and press them to support legislation to reverse this tragic decision so future patients won’t face the same dilemma.
Richard J. Arsenault, 2011
