BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 2983853 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01633
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 25, 2013
    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 Location
    WI
    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 PATIENT HAD FALLEN DAYS AFTER CHRISTMAS. THE PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW UP AND NOISE WAS NOTED ON THE VENTRICULAR LEAD. THE NOISE COULD BE REPRODUCED WITH ISOMETRICS. THE PULSE GENERATOR SENSITIVITY WAS DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88695 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR