BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D, OUS MODEL, DF1COMP

    MDR report key: 6453001 · Received April 3, 2017

    Report

    Report Number
    2938836-2017-20243
    Event Type
    Injury
    Date Received
    April 3, 2017
    Date of Event
    March 27, 2017
    Report Date
    April 10, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION RECEIVED, THE DEVICE WAS PROPHYLACTICALLY 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.

    Additional Manufacturer Narrative · 1

    PLEASE RETRACT THIS MDR 2938836-2017-20243. THE COMPLAINT WAS REPORTED AND FILED , 2938836-2017-19775.

    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.

    Description of Event or Problem · 1

    DUPLICATE OF PER-2017-0051290.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236753 UNIFY QUADRA CRT-D, OUS MODEL, DF1COMP IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3251-40 3386776

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention