BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D

    MDR report key: 4153501 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16384
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    July 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE REMOTE TRANSMISSIONS REVEALED THAT LOW LEVEL HIGH FREQUENCY NOISE WAS BEING SENSED AS THE R-WAVE. PROGRAMMING CHANGES RESOLVED THE OVERSENSING. THE PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631167 UNIFY ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3357-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR