BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2071202 · Received April 27, 2011

    Report

    Report Number
    2649622-2011-07352
    Event Type
    Death
    Date Received
    April 27, 2011
    Date of Event
    December 24, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL LEGAL COMMENT REPORT WITH A (B)(6) 2008 ALLEGING THE LEAD CAUSED THE DEATH WITH A NOTIFICATION DATE WAS EVALUATED AND ASSESSED TO BE NOT REPORTABLE INCORRECTLY IN 2008. THE INITIAL 3500A WAS CANCELLED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE PATIENT IS INVOLVED IN A SETTLEMENT INVOLVING THE SPRINT FIDELIS LEADS. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A LAWSUIT ALLEGED THAT THE PATIENT DIED AND THAT "THE IMMEDIATE CAUSE OF DEATH WAS A MYOCARDIAL INFARCTION, A CONDITION WHICH THE IMPLANTABLE CARDIAC DEFIBRILLATOR AND DEFIBRILLATION LEAD WERE DESIGNED AND MANUFACTURED TO PREVENT". ANOTHER ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT IS DECEASED. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATION THE PATIENT DIED APPROXIMATELY FIVE MONTHS POST THE IMPLANT OF THE IMPLANTABLE CARDIAC DEFIBRILLATOR AND LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death