BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 2905226 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00833
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 12, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z0429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THAT THE PULSE GENERATOR WAS INTERROGATED AND 12649 AMS EPISODES AND 13 NOISE RELATED EPISODES WERE OBSERVED. MOST OF THE EGM'S EXHIBITED ATRIAL NOISE. THE NOISE COULD BE REPRODUCED WITH ARM/SHOULDER MOVEMENT. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10758 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION PM2212 NA

    Patients

    Seq Age Sex Outcome Treatment
    1