Medtronic has announced a monitoring program to help detect a lead failure in patients affected by the Medtronic leads recall. The program is called “Lead Integrity Alert” and is supposed to improve detection of lead fractures. The monitoring program has three primary goals for patients with defective Sprint Fidelis leads.
Less Shocks
• Alert triggered by two different scenarios: 1) oversensing coupled with nonsustained VT and 2) a fixed impedance
• Safely automatically extends the VF detection NID to 30/40, once alert is activated
Improved Monitoring
• Continuously monitors lead integrity-24/7
• CareAlertTM sent to clinic from wireless devices
Advance Warning
• 76% of patients receive a minimum of 3 days’ notice to seek medical attention1
• Audible alert sounds immediately, every 4 hours, and at the programmed time
1 Swerdlow CD, Gunderson BD, Stadler RW, et al. Inappropriate shocks due to Sprint Fidelis® ICD lead fracture may be reduced by programming more intervals for detection of ventricular fibrillation. Heart Rhythm. 2008;5(Supp 5S):S33. Presented Abstract: AB16-5.
Researchers, including Dr. Charles Swerdlow, developed a downloadable algorithm to help prevent inappropriate shocks in patients caused by defective Medtronic Sprint Fidelis leads. The algorithm can be downloaded into currently implanted cardioverter-defibrillators to detect lead fractures and alert the patient or their doctor before there is an inappropriate shock. In testing the new algorithm on data from 15,970 patients, it provided at least a 3 day warning in 76% of cases.
We represent all Medtronics recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronic leads recall attorney will contact you to answer any of your questions.
We are a law firm dedicated to helping those injured by Medtronic Sprint Fidelis Defibrillator Lead.
Medtronic Recall Lawsuit
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.
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