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John Humphrey's Articles in Legal Issues

  • Medtronic Sprint Fidelis Lead Recall 6949
    On October 15, 2007, Medtronic informed patients with Sprint Fidelis lead Model 6949 that their defibrillation lead was recalled. The Medtronic recall also affected patients with lead Models 6930, 6931 and 6948. Patients can identify which Medtronic lead they have by referring to their Patient ID card (wallet card) which will contain the model of their implanted lead. If a patient is unsure about which lead they have implanted they should consult with their physician.
  • Medtronic Leads Recall 6930
    As of October 2007, Medtronic was aware of at least 665 chronic fractures in returned Sprint Fidelis leads. The majority of these fractures (approximately 90%) have occurred in the anode or cathode conductors. The Medtronic Sprint Fidelis 6930 lead was included in the 2007 recall. There seems to be evidence that Medtronic has knowledge their Sprint Fidelis leads survival rate was unacceptable when compared to industry failure rates.
  • Medtronic Recalls 6948 Lead.
    The Medtronic Sprint Fidelis 6948 lead was removed from the market by Medtronic on October 15, 2007 due to the reporting of fractures in some wires and five patient deaths associated with the defibrillator leads. It is estimated there are around 268,000 Medtronic leads implanted in patients around the world. Medtronic’s Sprint Fidelis defibrillation leads were recalled because the leads (electronic wires) are prone to fracture or break causing major complications and the potential for patient ...
  • Medtronic Lead Recall
    On October 15, 2007, Medtronic, Inc. announced that it was recalling its Sprint Fidelis defibrillation leads. Medtronic announced that the recall was due to “the potential for lead fractures.” At the time of the recall, there were reports of at least five deaths associated with the defibrillator leads. The Food and Drug Administration classified the recall as “Class 1,” which is the most serious type of recall and involve situations where there is a reasonable probability that the use of the ...

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