Medtronic Inc.’s Sprint Fidelis Defibrillator Lead recall has resulted in a shareholder lawsuit against the company.   The plaintiff filing the lawsuit accuses Medtronic of withholding information regarding defects in the Sprint Fidelis Defibrillator lead.  

Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

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Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, said its profits have slipped 2% as a result of last month’s Sprint Fidelis recall.  To make matters worse for the company, many are now asking if Medtronic acted quickly enough to get its faulty Sprint Fidelis Lead wires off the market.

Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

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People with a Medtronic or St. Jude implantable defibrillators should know that  some of these defibrillators’ lead wires—specifically in the Medtronic Sprint Fidelis and St. Jude Riata lead wires—have fractured, perforated patient heart walls, or caused device failure.  In some cases, these malfunctions of the Medtronic Sprint Fidelis Lead and the St. Jude Riata Defibrillator Lead  have led to additional cardiac procedures or complications and even death.

Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops.  A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the defibrillator.  When a defibrillator wire detaches or breaks, the device will fail leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock.  If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition where pressure builds around the heart preventing it from beating effectively.  Unfortunately, heart perforation is generally discovered after the wire has made it through the heart wall.

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