Defective Sprint fidelis Leads
Medtronic, Inc., the largest maker of ICDs (implantable cardioverter defibrillators) announced on Oct. 15, 2007 that it planned to voluntarily suspend the sale and distribution of a critical component of their ICDs?the Sprint Fidelis "lead," which is the wire that links the ICD to the heart. Medtronic stated that some leads are defective and may cause serious injury or death. So far, the leads may have contributed to the death of five individuals and serious injury of hundreds more.
Fractured Lead Wires
Some of the leads are defective and have fractured, causing the ICDs to (1) give a false signal that causes an inappropriate defibrillator shock, or (2) not give the appropriate or needed shock or pacing to the ICD.
The leads are threaded through a patient's blood vessel and are very difficult to remove. Both Medtronic and the FDA recommend that patients with a Sprint Fidelis lead see their physician about having their ICD reprogrammed rather than have the lead removed.
About 268,000 Sprint Fidelis leads are in place in patients worldwide. The four models of the defective Sprint Fidelis lead (6930, 6931, 6948, 6949) have been used with Medtronic ICDs only since 2004. Individuals who have had their defibrillator replaced recently probably do not have one of the defective Sprint Fidelis leads, since physicians usually attach a new defibrillator to the existing lead.
No ICDs are the subject of the latest recall by Medtronic. In early 2005, Medtronic did announce that some of their ICDs and other defibrillators had a battery problem that could cause their devices to fail. In the present action, it is Medtronic leads, not ICDs, that have been shown to be defective in some cases.
Medtronic's Warning Letters
Medtronic has begun contacting the approximately 13,000 doctors around the world who are caring for patients with potentially defective Sprint Fidelis leads. The company's warning letter notes that lead fractures may result in "inappropriate shocks and/or loss of output." Medtronic's letter to patients with Medtronic heart devices advises patients to contact their physicians about their options.
Contact an Attorney for More Information
If you or your family member received an ICD with a Medtronic Sprint Fidelis lead, contact your physician for medical advice, and then contact our Medtronic lawyers to discuss your legal rights and options.
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