Medtronic Sprint Fidelis 6949 Lawsuit Class Action Recall Updates | Attorney Lawyer
The Minneapolis Heart Institute conducted a study of the Medtronic Sprint Fidelis 6949 lead and determined that the lead had a greater failure rate compared to the Quattro lead. In October 2007 Medtronic announced a recall of Sprint Fidelis lead 6949 along with leads 6948, 6930 and 6931.
Medtronic Lead Failure
Minneapolis Heart Institute Foundation Study
Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead.
Hauser RG, Kallinen LM, Almquist AK, Gornick CC, Katsiyiannis WT.
BACKGROUND: We have observed a higher than expected rate of Sprint Fidelis model 6949 lead failures in our practice.
OBJECTIVE: The aim of this study was to assess the performance of small-diameter Sprint Fidelis high-voltage ICD leads.
METHODS: The actuarial survival of Sprint Fidelis model 6949 leads implanted at our center was compared with that of the Sprint Quattro Secure model 6947. The United States Food and Drug Administration Manufacturers and User Facility Device Experience (MAUDE) database was searched for Sprint Fidelis models.
RESULTS: The survival of 583 Sprint Fidelis 6949 leads implanted at our center between September 2004 and February 2007 was significantly less than 285 Sprint Quattro Secure model 6947 leads implanted by us between November 2001 and February 2007 (P = .005). Six patients presented with Sprint Fidelis lead failure 4-23 months after implant. Five of the six patients experienced multiple inappropriate shocks associated with pace-sense conductor and coil fractures; the sixth patient had a fixation mechanism failure. The MAUDE search rendered reports for 679 Sprint Fidelis leads. The most frequent complaints or observations were inappropriate shocks (33%), high impedance (33%), and fracture (35%). Of 125 leads analyzed by the manufacturer, 62 involved fracture of the pace-sense conductor or coil and the high-voltage (defibrillation) conductor.
CONCLUSIONS: The Sprint Fidelis high-voltage lead appears to be prone to early failure. Its use should be limited until the failure mechanism is identified and corrected. Patients should be evaluated quarterly, and automatic lead test features should be enabled. While more data are needed, routine prophylactic replacement of intact, normally functioning Sprint Fidelis leads does not appear justified. PMID: 17599673 [PubMed - indexed for MEDLINE]
Reprinted courtesy of PubMed.gov, a service of the U. S. National Library of Medicine and the National Institutes of Health
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U.S. Food & Drug Administration Statement On Medtronic Sprint Fidelis Defibrillator
Medtronic Suspends Sprint Fidelis Defibrillation Leads (PDF)
U.S. FDA Class 1 Recall Report
If you or a loved one have been injured by the Medtronic Sprint Fidelis lead please contact us immediately. You may be entitled to compensation.
Some people who have been harmed by defective Medtronic leads have filed lawsuits against the manufacturer. But, before filing a Medtronic lead lawsuit, there are several things that you should know.
Which product is defective?
Medtronic Sprint Fidelis defibrillator leads were more prone to fracturing than previous generation models of leads. Defibrillators are implanted heart devices that [...]
Medtronic manufactured a type of heart defibrillator lead that had defective wires. The defective wires were “leads,” which connected the defibrillator to the heart. The leads would fracture, or break, on numerous defibrillators. The Medtronic lead fracture was deadly in some patients.
Which defibrillators were defective?
The Medtronic lead fracture would occur in the Medtronic Sprint Fidelis [...]
Medtronic has been has been involved in litigation for defective Sprint Fidelis heart defibrillator leads. These Medtronics lawsuits were initiated because the “leads,” which are wires that connect the defibrillator device to the heart, could break, causing serious injury, and even death in some patients.
How many defective leads were produced?
More than 268,000 Medtronic Sprint Fidelis [...]
If you are seeking Medtronic lawsuit dismissed 2010 information and news about the recall related to your internal cardioverter defibrillator, we can provide the necessary background, facts and resources you need.
Medtronic Defibrillator
Medtronic is a manufacturer of a variety of medical products, notably of the Medtronic defibrillator. The internal cardioverter defibrillator is a small computer that [...]
Patients across the country continue to file Medtronic Sprint Fidelis lawsuit claims spurred by lead recall of the Sprint Fidelis wires. As patients face long-term side effects from the faulty defibrillator wires, they seek compensation from the company they believe knew of the wire problems long before the recall was issued.
A defibrillator is a life-saving [...]
