BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 3923066 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14405
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 17, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 AN ASYMPTOMATIC PATIENT PRESENTED FOR ROUTINE FOLLOW UP. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED NOISE REVERSION; THE DEVICE WAS OVERSENSING ON THE ATRIAL CHANNEL. PROGRAMMING CHANGES WERE NOT MADE. THE DEVICE REMAINED IMPLANTED AND THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399627 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR