BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR ICD, US

    MDR report key: 6147829 · Received December 6, 2016

    Report

    Report Number
    2938836-2016-15602
    Event Type
    Injury
    Date Received
    December 6, 2016
    Report Date
    November 29, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERROGATION OF THE DEVICE REVEALED IT WAS ABOVE ERI WHEN RECEIVED. BASED ON THIS INFORMATION, THE DEVICE WAS FOUND TO COMMUNICATE APPROPRIATELY WITH A MERLIN PROGRAMMER AND HAS NOT REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI).

    Additional Manufacturer Narrative · 1

    INTERROGATION OF THE DEVICE REVEALED IT WAS ABOVE ERI WHEN RECEIVED. BASED ON THIS INFORMATION, THE DEVICE WAS FOUND TO COMMUNICATE APPROPRIATELY WITH A MERLIN PROGRAMMER AND HAS NOT REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI).

    Additional Manufacturer Narrative · 1

    UDI NUMBER: (B)(4). A DECISION WAS MADE ON 29 NOVEMBER 2016 TO REPORT ALL PROPHYLACTIC EXPLANTS THAT ARE REPORTED TO ST. JUDE MEDICAL (SJM). THEREFORE, 29 NOV 2016 IS USED AS THE AWARE DATE FOR ALL PROPHYLACTIC EXPLANTS OCCURRING PRIOR TO THIS DATE. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ALTHOUGH THERE WAS NO ERI ALERT OR ALLEGATION OF PREMATURE BATTERY DEPLETION, THE DEVICE WAS EXPLANTED PROPHYLACTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799615 FORTIFY ASSURA DR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. CD2359-40QC 4521903

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention