BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, U1.6 SJ4 US

    MDR report key: 6207486 · Received December 27, 2016

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    Report

    Report Number
    2938836-2016-19780
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 29, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DECISION WAS MADE ON (B)(6) 2016 TO REPORT ALL PROPHYLACTIC EXPLANTS THAT ARE REPORTED TO ST. JUDE MEDICAL (SJM). THEREFORE, (B)(6) 2016 IS USED AS THE AWARE DATE FOR ALL PROPHYLACTIC EXPLANTS OCCURRING PRIOR TO THIS DATE. BASED ON THE INFORMATION RECEIVED, THE DEVICE WAS PROPHYLATICALLY REMOVED AND THERE IS NO ALLEGED MALFUNCTION OF THE PRODUCT. SHOULD THE DEVICE BE RETURNED AND THE ANALYSIS RESULTS INDICATE AN ANOMALY A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4). THE INITIAL REPORT FOR THIS EVENT WAS SUBMITTED WITH AN INCORRECT MFR REPORT NUMBER. THE INITIAL REPORT IS BEING RE-SUBMITTED WITH THE CORRECT MFR REPORT NUMBER.

    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
    855406 FORTIFY DR, U1.6 SJ4 US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. CD2231-40Q 3156562

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention