BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D

    MDR report key: 3903686 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12800
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 19, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION SHOWED VENTRICULAR NOISE INDICATIVE OF MYOPOTENTIAL OVERSENSING. A SUBSEQUENT MERLIN.NET TRANSMISSION SHOWED FUNCTIONAL LOSS OF CAPTURE WITH BIVENTRICULAR PACING. THE PATIENT WAS BROUGHT IN FOR TESTING AND THE THRESHOLDS WERE IN NORMAL RANGE AND HAD NOT FLUCTUATED. THE PATIENT WAS ASYMPTOMATIC. THE RECOMMENDED PROGRAMMING CHANGES WERE MADE RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380275 UNIFY ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3357-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR