Medtronic Leads Recall | Medtronics Recall Updates
Medtronic Lead Fractures Monitoring
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.
Defective Medtronic Leads
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.
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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 [...]
