BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP

    MDR report key: 6130960 · Received November 28, 2016

    Report

    Report Number
    2938836-2016-14952
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z-0116-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALTHOUGH THERE WAS NO ERI ALERT OR ALLEGATION OF PREMATURE BATTERY DEPLETION, THE DEVICE WAS EXPLANTED PROPHYLACTICALLY FOLLOWING THE ADVISORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779995 UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3251-40Q 3881118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention