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: Tennessee Law BlogMedtronic Sprint Fidelis Deaths ? 13 Admitted Fatalities from Defective Heart Device
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.
Full post as published by Tennessee Law Blog on March 24, 2009 (boomark / email).
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