BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA CRT-D RF HV

    MDR report key: 6205077 · Received December 27, 2016

    Report

    Report Number
    2938836-2016-22160
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 8, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    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
    854674 UNIFY ASSURA CRT-D RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3357-40C 4739801

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention