BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D

    MDR report key: 3911059 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12964
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 14, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE ICD WAS REPROGRAMMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VIA MERLIN.NET TRANSMISSION, MYOPOTENTIAL OVERSENSING WAS OBSERVED. PROGRAMMING CHANGES WERE RECOMMENDED. PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385824 UNIFY ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3357-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR