BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, U1.6 DF1 ID

    MDR report key: 6145552 · Received December 5, 2016

    Report

    Report Number
    2938836-2016-15486
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 7, 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

    ON DEC. 5, 2016, MDR (B)(4) WAS SUBMITTED FOR EVENT NUMBER PER-2016-0134697 (EMDR # (B)(4)).ON DEC. 13, 2016, MDR (B)(4) WAS SUBMITTED FOR EVENT NUMBER PER-2016-0132389 (EMDR # (B)(4)) FOR THE SAME PRODUCT COMPLAINT. FOR THIS REASON, PER (B)(4) WAS CREATED IN ERROR AS IT IS A DUPLICATE OF THE ORIGINAL FILE PER (B)(4).

    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.

    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
    795727 FORTIFY VR, U1.6 DF1 ID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. CD1233-40 3298644

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention