BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE PLUS CRT-D, DF4 CONNECTOR

    MDR report key: 3220077 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04516
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 20, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POSSIBLE OVERSENSING OF T-WAVES WAS OBSERVED ON THE VENTRICULAR CHANNEL AFTER BIV PACED EVENTS. PROGRAMMING CHANGES WERE RECOMMENDED. THE PHYSICIAN DECIDED NOT TO REPROGRAM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320928 PROMOTE PLUS CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR