BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA DR CRT-D

    MDR report key: 3854604 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11470
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 3, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP, ONE DAY AFTER DEVICE REPLACEMENT, MYOPOTENTIAL OVERSENSING WAS OBSERVED ON STORED NON-SUSTAINED OVERSENSING EPISODES. PROGRAMMING CHANGES WERE MADE AND THE ISSUE WAS RESOLVED. PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331818 QUADRA ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR