BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR, U1.6 DF1 ID

    MDR report key: 8949526 · Received August 30, 2019

    Report

    Report Number
    2938836-2019-13005
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    July 4, 2019
    Report Date
    September 25, 2019
    Manufacturer
    ABBOTT
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ADVISORY NOTICE ISSUED BY ST. JUDE MEDICAL ON 11 OCTOBER 2016.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: 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).

    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 DURING AN UNRELATED PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS REPLACED DURING AN UNRELATED PROCEDURE DUE TO NEARING NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745075 FORTIFY DR, U1.6 DF1 ID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ABBOTT CD2233-40 3141450

    Patients

    Seq Age Sex Outcome Treatment
    1