BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE PLUS CRT-D, DF4 CONNECTOR

    MDR report key: 3210534 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03418
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 30, 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
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ASYMPTOMATIC PATIENT PRESENTED IN A HOSPITAL EMERGENCY ROOM WITH POST-PACED T-WAVE OVER-SENSING OBSERVED. THE PATIENT DID NOT RECEIVE THERAPY DUE TO OVER-SENSING. PROGRAMMING CHANGES WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310666 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 64 YR