BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 3923115 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14451
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 14, 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
    FL, 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 UPON INTERROGATION PRIOR TO IMPLANT THE PULSE GENERATOR DISPLAYED AN ERROR MESSAGE. THE DEVICE WAS SUCCESSFULLY RESTORED TO NOMINAL SETTINGS. THE DEVICE WAS IMPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401399 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR