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
If you or a loved one has questions regarding the Medtronic Sprint Fidelis 6949 lead recall please contact us and a Sprint Fidelis lawsuit attorney can help answer your questions. We offer a free, confidential no-obligation consultation to individuals and families affected by the Medtronic recall.
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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.
Patients subject to the Sprint Fidelis recall continue to suffer from a Medtronic lead failure leading to a surgery to replace the defective lead. The Multidistrict Medtronics lawsuit is currently under appeal and lawyers representing victims are continuing to fight for the right to bring a claim for compensation.
If you have been diagnosed with an [...]
In January 2009 the United States District Court ruled the Sprint Fidelis Medtronic Lawsuit Dismissed. This ruling is currently under appeal and attorneys representing patients and families affected by the Medtronic recall continue to fight for their rights. The Medtronics recall involves only the Sprint Fidelis lead and not the implanted heart device.
The defibrillator lead [...]
The Medtronic lead lawsuit Multidistrict litigation continue even though there have been setbacks and we continue to push for the Medical Device Safety Act legislation which will help protect patients with medical devices. The Sprint Fidelis recall failure rate of defibrillator leads continues to leave heart patients in the difficult position of not knowing if [...]
It is estimated there are 150,000 heart patients throughout the United States affected by the Medtronic lead recall who have a recalled defibrillator lead wire and are at risk of a lead fracture. Medtronic lawsuits continue to be filed on behalf of patients who have suffered a lead fracture. The Medtronic Sprint Fidelis leads were [...]
Patients continue to suffer from a Medtronic Sprint Fidelis lead fracture following the 2007 Medtronic recall of defibrillator leads. If you or a loved one has suffered from fractured leads please contact us today for a free consultation and information how we can help.
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