Parker Waichman LLP

Risks Grow Over Time for Medtronic’s Sprint Fidelis Lead

Sprint Fidelis defibrillator leads still putting patients at risk. A new study has found that Medtronic’s Sprint Fidelis defibrillator leads are still putting patients at risk. The Sprint Fidelis leads were removed from the market in October 2007 because of their higher-than-normal fracture rate. A lead is a wire that connects an implantable defibrillator to the […]

Medtronic Sprint Fidelis

Sprint Fidelis defibrillator leads still putting patients at risk. A new study has found that Medtronic’s Sprint Fidelis defibrillator leads are still putting patients at risk. The Sprint Fidelis leads were removed from the market in October 2007 because of their higher-than-normal fracture rate.

A lead is a wire that connects an implantable defibrillator to the heart. If a lead  breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear.

In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture.

Medtronic suspended sales of its Sprint Fidelis leads 07

Medtronic suspended sales of its Sprint Fidelis leads in October 2007, after receiving reports of 5 fatalities linked to lead fractures.  Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators.

According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued.

According to a report in The Wall Street Journal, the researchers who first spotted problems with Sprint Fidelis leads have found that the risk of a fracture increases as the device ages.

According to cardiologists at the Minneapolis Heart Institute, out of  3,037 patients implanted with defibrillator leads of varying models, a total of 94 leads failed. Seventy-two of the failures were Sprint Fidelis leads, out of 848 Sprint Fidelis leads implanted, The Wall Street Journal said.

The study, published in the journal HeartRythm, saw a Sprint Fidelis failure rate of 3.75% a year, compared with 0.58% among other models. At three years after implant, 87.9% of the Sprint Fidelis leads were working, compared with 98.5% for other models studied.

“The hazard of the Sprint Fidelis lead is increasing, while the failure rate of other defibrillator leads are low and stable,” the study authors wrote.

About 150,000 Sprint Fidelis leads remain implanted in U.S. patients

These findings mean that the Sprint Fidelis lead is still putting thousands of patients at risk. According to The Wall Street Journal, it is estimated that about 150,000 Sprint Fidelis leads remain implanted in U.S. patients.

Not surprisingly, the Sprint Fidelis defects spawned scores of personal injury lawsuits.  Unfortunately, as we reported earlier this month, the future of those lawsuits was placed in doubt when a federal judge in Minneapolis dismissed hundreds of them.

In dismissing the claims, the judge cited a Supreme Court ruling issued last year that barred personal injury lawsuits against device makers when a device has been approved by the Food & Drug Administration.

Need Legal Help Regarding Medtronic Sprint Fidelis?

The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Great place. Good service and helped with everything needed.
Bus Ministry
6 years ago
5 Star Reviews 150
My Experience with the lawyer Jessie Salcedo has been excellent, she has helped me at all times and answered any questions I had at some point. Thank you! Jessie Salcedo Paralegal Parker Waichman LLP
Keisha Reyes
4 years ago
5 Star Reviews 150
I'd like to say a few words about Joanne Stevens, NP. From the first phone call she answered ALL my questions and set me at ease with her knowledge and empathy. She calls me frequently and anytime I call her and get her VM, she returns my call within 24 hrs. without fail. I gave her 5 stars but she deserves 10. Thank you Joanne Stevens, just THANK YOU. Tina Schlobohm
Tina Schlobohm
4 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038