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April 11, 2008

Medtronic sued again over fractured defibrillator leads

A lawsuit has been filed against Medtronic in Indiana alleging the defective Sprint Fidelis leads in its heart defibrillator resulted in inappropriate shocks, severe pain and hospitalization. The malfunctioning lead wires fractured causing the defibrillator to send unnecessary and painful shocks to the client’s heart. The defibrillators monitor the heart rhythm and will deliver electric shocks directly to the heart if it begins to beat erroneously. The shocks are delivered via the lead wires. The suit also claims that Medtronic concealed or downplayed the known health risks so they could continue marketing and selling the device globally. On Oct. 15, 2007, Medtronic removed its Sprint Fidelis heart defibrillator cardiac leads from the market after reports surfaced that linked the devices to patient deaths. As of now 5 deaths have been attributed to the defective medical device. The same day, the FDA concurred and said it was aware of deaths and major complications associated with the fractured leads.

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