BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP CRT-D

    MDR report key: 4760363 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04614
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    March 27, 2015
    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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE REGISTERED AUTO MODE SWITCHING EPISODES THE DAY AFTER IMPLANT DUE TO SUSPECTED CROSS TALK. THE CAUSE OF OVERSENSING WAS THE DIFFERENT SENSING FILTER FROM THE PREVIOUS DEVICE. REPROGRAMMING RECOMMENDED CHANGES WERE NOT MADE. THE VENTRICULAR LEAD WAS REPOSITIONED. THE PATIENT CONDITION IS GOOD. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303668 QUADRA ASSURA MP CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3371-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 COMPETITOR GDT4096 191125