BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 3920565 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14158
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION UNIT HAD BEEN PLACED ON THE PATIENTS SHOULDER, THE PATIENT LOST CONSCIOUSNESS. THE PULSE GENERATOR EXHIBITED NOISE EPISODES IN BOTH THE ATRIAL AND VENTRICULAR CHANNELS. THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396776 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2212 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR