BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4140280 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05928
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 10, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED IN CLINIC DUE TO A MESSAGE THAT INDICATED DEVICE RESET HAD OCCURRED. AN ERRONEOUS PARAMETERS DETECTED ERROR MESSAGE PRESENTED DURING A DEVICE INTERROGATION. THE DEVICE WAS TEMPORARILY REPROGRAMMED TO NOMINAL SETTINGS TO CLEAR THE ERROR MESSAGE. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29254 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR