BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D

    MDR report key: 4221030 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17467
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD COMPLAINTS OF POCKET DISCOMFORT. DEVICE WAS NEARING ERI, AND WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703071 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention