BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4151777 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-06364
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 30, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC, CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF SET SCREW FAILURE COULD BE CONFIRMED IN THE LABORATORY. ANALYSIS FOUND MEDICAL ADHESIVE INSIDE BOTH SET SCREWS INSETS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET SCREW FAILED TO WORK PROPERLY. THE PACE MAKER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27781 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY DXY ST. JUDE MEDICAL, INC, CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR