Defibrillator Leads Can Puncture Heart

Defective Medical Devices

Yet another problem has arisen with implanted defibrillators. In 2005, problems were found with two major brands of implantable defibrillators. First several Medtronic defibrillators were found to suffer battery short-outs. Then Guidant corporation (now a subsidiary of Boston Scientific Corporation) announced a recall of 20 models of its implantable defibrillators. Earlier this year, Medtronic also announced problems with several models of its Sprint Fidelis leads that could lead to painful shocks or even death for patients, problems of which it was apparently aware for seven months before its “voluntary suspension of sale” of the leads.

Now an entirely different brand of defibrillator leads is apparently causing an entirely different brand of problems. According to the journal of Pacing and Clinical Electrophysiology, the Riata leads manufactured by St. Jude Medical, Inc can actually puncture the heart of patients. The report is based on only four cases, two in the Czech Republic, and two in the United States, and, according to St. Jude’s data based on 121,000 cases, the perforation rate is only 0.086 percent, or approximately 86 cases per 100,000 patients.

Apparently, perforation by leads is not a new thing, but is pandemic with implanted defibrillators, dependent on a physician’s technique or characteristics of the patient, meaning this may be less a case of defective product and more of medical malpractice. Or is it? These devices are purported to be consistent with the highest level of medical care available, but with the incidence of all these problems, one wonders whether they are worth the cost or whether the medical supply corporations are profiteering on the tendency of the human heart to hope.

If you or someone you love pinned your hope on one of these devices, only to find that the device itself was as much a threat as the disease, please contact today to get in touch with a local lawyer who is ready to take up your case.