St. Jude Medical Cardiac Defibrillators

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St. Jude Medical Cardiac Defibrillators

St. Jude Medical Inc., a Canada-based medical technology company, announced in June 2005 that some of its implantable defibrillator models, or ICDs, have a software problem that could cause the heart-shocking device to malfunction.

Affecting about 39,000 patients, the St. Jude cardiac defibrillators need a brief, noninvasive upgrade that can be done during an office checkup, according to the company. When the St. Jude cardiac defibrillator announcement was made, the news involving the potential device malfunctions followed news that rival company Guidant Corp. had recalled 50,000 of its ICDs in the previous week. Earlier in the year, another ICD device company, Medtronic, recalled 87,000 of its defibrillators because of a battery depletion problem.

The two Guidant safety alerts in one week panicked investors and patients, leaving some investment firms to upgrade competitors Medtronic and St. Jude cardiac defibrillators. Because Guidant’s reputation was already suffering due to the alerts and recalls, some analysts believed it would be hard for the company to win back customers – driving some of them to St. Jude cardiac defibrillators.

Instead, St. Jude cardiac defibrillators were also found to have “anomalies” during a routine product evaluation. Both the Atlas and Epic implantable defibrillator models were affected by the software problem. One of the problems among St. Jude cardiac defibrillators existed in units past their mid-life. Instead of administering a series of shocks as the device delivered its routine of multiple shocks to revitalize the patient’s heart, the St. Jude cardiac defibrillators would skip them. After the first shock was delivered the device would sometimes send fewer than the maximum of six shocks per episode.

The second problem among affected St. Jude cardiac defibrillators was a temporary increase in the device’s pacing rate. Some patients needed an ICD to pace their hearts in addition to its shocking therapy. The company provided doctors with a software tool to correct the programmers - a tabletop computer that permits noninvasive communication with the implanted device.

According to the company, a wand placed on the patient’s chest would allow the computer to determine if the ICD is among the affected St. Jude cardiac defibrillators. If the patient has an affected defibrillator, the new software would be downloaded to the device in a procedure that would take 45 seconds, according to St. Jude, and company representatives would install the corrective software.

Affected by the St. Jude cardiac defibrillator warnings were the Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-239T/V-196T/V-350), Atlas DR (V-242) and Atlas Plus DR/VR/HF (V-243/V-193/V-193C/V-340/V-341/V-343) models. An ICD is supposed to protect against sudden cardiac death from ventricular tachycardia and ventricular fibrillation. Defects in the device could be, as a result, completely devastating. For more information on the safety notification affecting St. Jude cardiac defibrillators, please contact us to confer with an attorney.

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