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PhoneMedtronic 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:
|
9/2004 |
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. |
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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. |
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1/2006 |
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 |
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1/2007 |
Study 17% incidence of abnormal sensing in patients with one of the recalled leads |
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3/2007 |
Dear Dr. Letter reporting |
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7/2007 |
1000 Medical Device reports to the FDA - MDT looked at 125 occurring before July 2006 & found 66% were defective |
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8/2006 - 2/2007 |
MDT filed another 350 reports, but allegedly have not completed an analysis |
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10/15/2007 |
Publication re: Notice from Medtronic |
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10/15/2007 |
Lawsuits filed in San Juan, PR & MN |
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1/30/2007 |
JPML Hearing regarding MDL |