Medtronic Recalls Defibrillator | Levin Papantonio Rafferty - Personal Injury Law Firm

Medtronic Recalls Defibrillator Wires

On October 15, 2007, Medtronic, Inc. announced that several of the electrical wires it sells were defective and may have contributed to the deaths of at least 5 patients by failing to deliver a necessary shock. If you or a loved one were implanted with a Medtronic Sprint Fidelis lead wire (Model 6930, 6931, 6948, or 6949), you may have a valuable claim against Medtronic.

Medtronic Lead Wire Case:

10/15/2007 - Medtronic sent out notice about defective lead wires prone to fracture and failure within 14 months after implant, and which may have contributed to 5 deaths. Reports estimate approximate 235,000 wires currently implanted.

Treatment Options:
(1) Change settings
(2) Turn on the Lead Performance Alert system - to increase likelihood of detection of fracture
(3) Cap the lead - stretch the vein to add another lead
(4) Remove the lead which carries a 7 - 10 % chance of major complications (lethal bleeding, tear in the vein or heart; or life-threatening infection)

Brief Timeline:


MDT markets new lead called the Sprint Fidelis (Fi-de-lees) (Latin for Faithful) to increase market share - smaller lead over their Quattro that had been on the market since 2001.

9/2004 -2/2007

583 patients implanted with at least one model of the recalled devices & 6 experienced lead failures. Average failure time is 14 months.


Article by the Heart Rhythm Society reported
- Failure rate of on of the 4 models was 10x greater than Quattro
- Fracture rate for others was three times higher than Quattro


Study 17% incidence of abnormal sensing in patients with one of the recalled leads


Dear Dr. Letter reporting


1000 Medical Device reports to the FDA - MDT looked at 125 occurring before July 2006 & found 66% were defective

8/2006 - 2/2007

MDT filed another 350 reports, but allegedly have not completed an analysis


Publication re: Notice from Medtronic


Lawsuits filed in San Juan, PR & MN


JPML Hearing regarding MDL