BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE ACCEL CRT-D

    MDR report key: 3854614 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11552
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 17, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN THE EMERGENCY ROOM WITH THE DEVICE POST-PACED T-WAVE OVERSENSING. NO SENSING CHANGES OR DEVICE CHANGES WERE MADE. PATIENT WAS FINE AFTER THE EVENT AND WILL CONTINUE WITH ROUTINE FOLLOW-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332370 PROMOTE ACCEL CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3215-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR