BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4121567 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07708
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 16, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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 REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THE REPORTED FIELD EVENT OF SETSCREW ANOMALY WAS NOT CONFIRMED. ATRIAL SETSCREW WAS NOT RETURNED, THEREFORE COMPLETE SETSCREW ANALYSIS COULD NOT BE PERFORMED. ATRIAL SEPTUM AND ATRIAL CONNECTOR BLOCK WAS DAMAGED. THE DEVICE WAS TESTED AND NO ELECTRICAL ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE SETSCREW COULD NOT BE LOOSENED. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32469 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY DXY ST. JUDE MEDICAL, INC., CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR