Medtronic Recall Lawsuit | Sprint Fidelis Defective Lead Attorney Lawyer

Following the Medtronic recall of their Sprint Fidelis heart leads the FDA released a statement covering the background of the Medtronic leads and recommendations.

Neither the FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model. The following Medtronic statement accompanied their letter to physicians on October 15, 2007.

Sprint Fidelis Lead Extraction Risks

October 2007
This attachment accompanies Medtronic’s physician letter dated October 15, 2007 and provides information concerning risks inherent in lead extractions.

Medtronic’s Independent Physician Quality Panel believes it is inappropriate to prophylactically remove Sprint Fidelis® leads except in unusual individual patient circumstances. We support this position.

Extraction of chronic leads entails substantial risks of patient morbidity and mortality. Reported complications1 include: lead breakage and migration; avulsion of veins, myocardium or the tricuspid valve; tears of the myocardium or veins; hemothorax, tamponade, perforation, emergency cardiothoracic surgery, pulmonary emboli, and death.

In evaluating whether to extract any cardiac lead, physicians must weigh the risks and benefits of leaving the lead in place in comparison to those of removal. Major complications from lead extraction, defined as death or the requirement of a significant surgical intervention, have been reported in multiple series to be in the range of 1.4-7.3% of patients.2,3 Factors reported to increase the risk of major complications include: duration of implant, female gender, and large removal sheaths.4,5

Medtronic Sprint Fidelis performance data indicate all-cause lead survival of 97.7% at 30 months (SLS, Medtronic CareLink® Network analysis). High voltage conductor fractures could result in the inability to deliver defibrillation therapy. Anode or cathode conductor fractures at either of the primary fracture locations may present clinically as increased impedance, oversensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output. Utilization of the patient management recommendations will increase the likelihood that a fracture will be detected by Patient AlertTM and/or Medtronic CareAlert® notifications (see Appendix C) and decrease the likelihood of inappropriate therapies. Based on current information, we have identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. (0.0018% of approximately 268,000 implants worldwide). By comparison, the risk of major complications (cardiac surgery or death) with lead extraction is 1.4-7.3%.

It has been reported that limited physician experience (< 50 procedures) may significantly increase the risk of complications from extraction.6 For this reason, Medtronic’s Independent Physician Quality Panel recommends that if a lead requires removal, the procedure be performed by a physician with extensive lead extraction experience.

These recommendations are consistent with the HRS Policy Statement on recommendations for extraction of chronically implanted leads.7

References
1. Byrd CL, Wilkoff BL, in Clinical Cardiac Pacing and Defibrillation, Ellenbogen, Kay and Wilkoff editors. WB Saunders 2000, Techniques and Devices for Extraction of Pacemaker and Implantable Cardioverter Defibrillator Leads: 695-709.
2. Byrd et al, Intravascular extraction of problematic or infected permanent pacemaker leads: 1994-1996. U.S. Extraction Database, MED Institute. PACE. 1999;22(9):1349-1357.
3. Bracke et al, Lead extraction for device related infections: a single-centre experience. Europace May 2004; 6(3):243-247.
4. Byrd et al. PACE. 1999;22(9):1349-1357.
5. Kennergren et al, Laser-assisted lead extraction: the European experience. Europace. August 2007; 9(8):651-656.
6. Byrd et al. PACE. 1999;22(9):1349-1357.
7. NASPE Policy Statement: Recommendations for Extraction of Chronically Implanted Transvenous Pacing and Defibrillator Leads: Indications, Facilities, Training. Love CJ, Wilkoff BL, et al. PACE. 2000; 23, 544-551.

If you have questions or concerns, please contact your Medtronic Representative or Medtronic Technical Services at 1-800-723-4636 (US).

If you or a loved one has been injured by a defective Medtronic defibrillator lead please contact us for a free consultation and case review. A Medtronic recall class action attorney can go over your legal rights and options and evaluate any potential claims you may have. You may be entitled to compensation and we can help.


MEDTRONIC LAWSUIT SEARCH

FIELDS LAW FIRM

We are a law firm dedicated to helping those injured by Medtronic Sprint Fidelis Defibrillator Lead.


Medtronic Recall Lawsuit
BOOKMARK THIS SITE
MEDTRONIC RECALL CATEGORIES
STAY UPDATED

RECENT ARTICLES
MEDTRONIC LAWYER


MEDTRONIC RECALL INSULIN INFUSION SETS
MEDTRONIC RECALL RESOURCES
FREE CASE CONSULTATION

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.


Name:
Email:
Phone:
State:
Message:
MEDTRONIC RECALL & LAWSUIT NEWS
Medtronic Lead Lawsuit 2010

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 Lead Fracture News

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 [...]

Medtronics Lawsuits News

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 [...]

Medtronic Lawsuit Dismissed 2010

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 [...]

Medtronic Sprint Fidelis Lawsuit

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 [...]

Copyright 2009 - 2010 Fields Law Firm a Medtronic Lead Recall Lawyer. Read Our Disclaimer Representing individuals and families related to Medtronic Sprint Fidelis leads, Medtronic defibrillator lead recall and Medtronic lead extractions. Medtronic recall 2010 updates including Sprint Fidelis lead recall, Medtronic lead lawsuit and Sprint Fidelis lawsuit. Medtronic lawsuit and Medtronics recall news and information for Medtronic class action. Serving clients suffering from Medtronic heart defibrillator lead side effects for 6949, 6948, 6931 & 6930 leads in Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, D.C., Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming.

Talk To A Medtronic Recall Lawyer / Attorney Now And Get Your Free Case Review - Toll Free (888) 343-5375