BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4143230 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05699
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 26, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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. THE REPORTED FIELD EVENT OF UNABLE TO TIGHTEN WAS CONFIRMED IN THE LAB. THE CONNECTOR BLOCK NOTED SOME MEDICAL ADHESIVE IN BETWEEN THREADS. CLOSE UP PHOTOGRAPHY INDICATED THAT THE V-TOP SETSCREW INSET WAS STRIPPED. THE MEDICAL ADHESIVE CLOGGED THE SETSCREW INSET MAKING IT DIFFICULT TO TIGHTEN SETSCREWS AND STRIPPING THE SETSCREW INSET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SETSCREW WOULD NOT TIGHTEN DURING IMPLANT. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32170 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR