BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4192277 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04106
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 3, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE REPORTED FIELD EVENT OF SETSCREW WOULD NOT TIGHTEN WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS VISUALLY EXAMINED, SEPTUM MATERIAL AND MEDICAL ADHESIVE WERE FOUND IN THE SETSCREW INSET. THE UPPER PORTION OF THE STRIAL SETSCREW INSET WAS OBSERVED TO BE STRIPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE ATRIAL SETSCREW DID NOT PRODUCT A CLICKING SOUND TIGHTENED USING HEX WRENCH. THE DEVICE WAS NOT IMPLANTED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32020 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC. CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR