Deaths from defective Medtronic heart devices continue despite recall in 2007. When Medtronic first announced its recall of Sprint Fidelis leads, the company acknowledged five defective device-caused deaths. This month, Medtronic updated its defective Sprint Fidelis death count to thirteen, nine of which due directly to defibrillator failure from faulty Sprint Fidelis leads.
Despite the Medtronic recall, the device remains in use. Many patients with Medtronic’s Sprint Fidelis leads face the difficult decision of to keep the prolific recalled device. One reason the medical device’s danger is so widespread is the delay in recalling Sprint Fidelis leads from market. Medtronic waited until 2007 for issuing their Sprint Fidelis recall; this despite FDA officials receiving reports of the device’s defective equipment as early as 2004. By year-end 2005, FDA had received 30 complaints about the device. Whether Medtronic knew of that defects in the Sprint Fidelis posed safety problems remains open to question.
The defective part of the heart medical device is a thin electrical wires (a lead) that can fail to fire when the defibrillator is needed to reset the patients erratically beating heart or can fire on its own. This lead is called the Sprint Fidelis.
Medtronic has temporarily been given carte blanche by a Supreme Court decision last year that prevented lawsuits against medical device manufacturers. A more recent decision by the Court in the Wyeth drug injury liability lawsuit and the introduction of legislature in Congress may reopen defective medical device lawsuits–what Medtronic has estimated to be about 2,000 alleged injuries (FDA estimates 2,200 serious or fatal injuries) caused by Sprint Fidelis leads.
Presently, about 150,000 U.S. citizens still have Sprint Fidelis leads in their bodies. Four of the acknowledged 13 deaths were the result of doctors attempting surgery to remove the defective product. Medtronic’s medical director, the doctor who updated the number of deaths to 13 this month, suggests patients who decide to remove his company’s potentially lethal medical product go to a skilled doctor who has previously performed the removal procedure. FDA officials suggest surgeons weigh the risk of continuing to use versus removing or capping the lead carefully.
Though the going may be slow at first in pursuing defective medical device lawsuits while our legal system recalibrates and returns legal protections and the right of restitution to those injured by medical device manufacturer’s negligence, I would like to know of your loved one’s injury caused by a defective Medtronic Sprint Fidelis lead or other medical device. If you or a loved one, whether in Tennessee, Kentucky, Georgia, or out-of-state, was injured by a malfunctioning medical device, my Nashville law offices would like to extend our legal help. Call (615) 353-0930 or fill out Higgins Firm’s medical device injury attorney form for a free initial consultation with a Tennessee defective medical device lawyer.