BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP CRT-D, DF-4 CONNECTOR

    MDR report key: 3903617 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12728
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 15, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SEVERAL AUTO MODE SWITCH EPISODES WERE OBSERVED DUE TO UNDERSENSING OF ATRIAL ACTIVITY. THE PHYSICIAN PERFORMED PROGRAM CHANGES. THE PATIENT WAS IN GOOD CONDITION BEFORE AND AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379274 QUADRA ASSURA MP CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3371-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1