Internal defibrillators that are implanted in heart patients to help control their heart rhythms are life-savers for many cardiac patients — another marvel of modern medicine. Defibrillators not only save lives but also help cardiac patients have a better quality of life. The implanted defibrillators are connected to patients’ hearts by insulated electrical wires known as “leads.” Possible problems with some of the leads in some of the defibrillators manufactured by different medical device companies have been in the news recently.
Possible problems with some defibrillator leads manufactured by St. Jude Medical Inc. (“St. Jude”) first surfaced in September, 2011, when a small study of revision surgeries regarding St. Jude’s so-called Riata leads reported problems with the leads that were higher than initially reported by St. Jude. The problem involved fracture of the leads that allegedly resulted in the deaths of some patients (a reported study by a cardiologist found that there were 22 deaths related to the Riata leads, which was disputed by St. Jude). The defect occurs when the insulation covering the leads suffer “insulation abrasion” that results in “externalized conductors” (lead wires poking through their insulation) that may deliver unintended electrical shocks to patients.
In December, 2011, St. Jude removed the Riata leads from the market that resulted in the FDA issuing a Class I recall (a Class I recall is the most serious, reserved for products that pose a potential risk of serious injury or death).
On May 1, 2012, St. Jude issued a report in which it stated that the recalled Riata leads “conductor fracture” rate increased by 4.3% during the last half of 2011 when compared to St. Jude’s earlier report regarding the conductor fracture rate in November, 2011. The May 1, 2012 report further indicated that the rate of “insulation breach” rose by 24.4% and the overall malfunction rate increased by 12.3%. Nonetheless, the malfunction numbers are acknowledged to be under-reported because St. Jude only tracts malfunctions that are reported to St. Jude from physicians.
It must be stressed that despite the statistics stated above, there were reportedly 69,257 Riata defibrillators in use in patients as of December 31, 2011, with 540 reported total insulation breaches and 37 reported total conductor failures as of that date. While the risk of failure, breach, or malfunction is very small, if you or a family member have an implanted Riata defibrillator, any chance of a failure, breach, or malfunction is disturbing.
If you or a loved one have or had a Riata defibrillator implanted, it would be important to discuss your situation and concerns with your cardiologist or other appropriate health care provider. If you have a legal concern about a malfunctioning Riata defibrillator or a defibrillator manufactured by another company, you should consult with a medical malpractice attorney regarding your particular situation.
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