BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 3903813 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12910
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    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 NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING WAS OBSERVED VIA MERLIN.NET TRANSMISSION. REVIEW OF THE EGM REVEALED POSSIBLE MYOPOTENTIAL OVERSENSING. IT WAS RECOMMENDED FOR PATIENT TO BE CHECKED FOR FURTHER INVESTIGATION AND PROGRAMMING CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380581 UNIFY ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR