BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4192279 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04103
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    May 12, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. A PARTIAL DEVICE WAS RETURNED FOR ANALYSIS WITH THE HEADER AND SET SCREW MISSING. WITHOUT RETURN OF THE ENTIRE DEVICE, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE SETSCREW WAS STRIPPED. THE PHYSICIAN WAS UNABLE TO REMOVE THE LEADS FROM THE HEADER AND HAD TO CRACK THE HEADER TO REMOVE LEAD. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31466 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC. CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR