BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4151039 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-06591
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 4, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    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

    ALL INFO WAS PROVIDED BY MFR, 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. EVAL DESCRIPTION: THE REPORTED FIELD EVENT OF SET SCREW NOT TIGHTENING WAS CONFIRMED IN THE LABORATORY. THE A TIP AND V TIP CONNECTOR BLOCKS NOTED SOME MEDICAL ADHESIVE IN BETWEEN THREADS. THE MEDICAL ADHESIVE POTENTIALLY CLOGGED THE SET SCREW INSET, MAKING IT DIFFICULT TO TIGHTEN THE SET SCREW AND STRIPPING BOTH SET SCREW INSETS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL SETSCREW WOULD NOT WORK PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31894 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR