MEDTRONIC DEFIBRILLATOR RECALL

by Jane Mundy

Medtronic defibrillator leads were recalled October 15, 2007 after at least five patient deaths have been linked to fractured Medtronic Sprint Fidelis leads. The leads were recalled because a risk of fractures can cause the defibrillator to either deliver unnecessary shocks or not deliver shocks when necessary.

The recalled defibrillator leads are the Sprint Fidelis Models: 6930, 6931, 6948, and 6949. Medtronic, the medical device firm based in Minneapolis, says that 268,000 Sprint Fidelis leads have been implanted and about 235,000 patients still have the leads. Medtronic estimates that more than two percent of these patients will suffer a lead fracture within 30 months of lead implantation.

The defibrillator leads could be even more problematic in young adults and children because they come under greater stress in more-active people. 2,085 leads were implanted in patients under the age of 21. Wayne H. Franklin, an associate professor at Northwestern University's Feinberg School of Medicine gathered preliminary data from physicians at 32 institutions. The data showed a fracture rate of 6.7% among 569 patients with Sprint Fidelis leads over 30 months and the "vast majority" of patients are likely to be under 21 years of age.

When a lead fractures, patients can get unnecessary and massive shocks, or not get the shock when they need it to save their lives after cardiac arrest. However, removing the leads can be difficult and dangerous, according to George Van Hare, a professor at Stanford Medical School who knows of two fractures among 40 pediatric patients who got Sprint Fidelis leads at his center.

Former users of Medtronic Sprint Fidelis cardiac leads are suing the company claiming injuries from the leads. The class action lawsuit alleges the lead wire portion of the implanted heart defibrillators was defective. According to the lawsuit, their defibrillators malfunctioned and jolted them unexpectedly.

People with defibrillators should determine whether they have been implanted with a recalled lead. They are advised to check the patient implant card received after surgery and contact their physician if there is any doubt. People with implanted leads should contact their physician if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.

[MORE ARTICLES]

Enter the information about your MEDTRONIC SPRINT FIDELIS case and we will contact you. Fields marked * are required.

First Name: *

Last Name: *

Email Address: *

Phone Number: *

State: *

Date of injustice: *

Describe the nature of your complaint in one short sentence: *

Details of complaint:
(briefly describe the damages you have suffered) *

Enter the text in the image below into the box at right:

Online Legal Resources