BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 2014172 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01837
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    November 12, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR EXHIBITED LOSS OF OUTPUT AND TELEMETRY DUE TO PREMATURE BATTERY DEPLETION. AFTER REPLACING THE BATTERY, THE PRODUCT CODE WAS DOWNLOADED AND NORMAL OUTPUT AND CURRENT DRAIN WERE MEASURED. RADIO FREQUENCY (RF) TELEMETRY COULD BE ESTABLISHED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR COULD NOT BE INTERROGATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1