BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2021065 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-03969
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    December 17, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0068-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE LEAD MODEL 6931 IS PART OF THE ADVISORY.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT "EXPERIENCED FRIGHTENING EPISODES OF UNNECESSARY SHOCKS AND HAS REQUIRED ADDITIONAL MEDICAL CARE ALONG WITH THE ASSOCIATED COSTS AS A RESULT OF THE DEFECTIVE" LEAD. "AFTER TREMENDOUS SUFFERING", THE PATIENT "ULTIMATELY DIED AS A RESULT OF THE DEFECTIVE" LEAD. APPROXIMATELY THREE YEARS LATER, AN ALLEGATION FROM A SECOND ATTORNEY INDICATED THE PATIENT IMPLANTED WITH A RIGHT VENTRICULAR LEAD IS DECEASED AND NO FURTHER INFORMATION WAS PROVIDED. FURTHER ASSESSMENT OF THE MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST IMPLANT THE IMPLANTABLE CARDIOVERSION DEFIBRILLATOR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6931 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| L| R