BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 4191842 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04317
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 12, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE REPORTED FIELD EVENT OF SET SCREW ANOMALY WAS CONFIRMED IN THE LABORATORY. THE SEPTUM MATERIAL CLOGGED THE SET SCREW INSET, MAKING IT DIFFICULT TO TIGHTEN THE SETSCREW AND ALSO, INDICATED THAT THE V TIP SET SCREW INSET WAS STRIPPED.

    Description of Event or Problem · 1

    IT WS REPORTED THAT PRIOR TO THE PATIENT BEING DISCHARGED, HIGH OUT OF RANGE IMPEDANCE WAS OBSERVED ON THE PACE MAKER. AFTER THE PHYSICIAN REINSERTED THE LEAD THE SET SCREWS WOULD NOT TIGHTEN. THE PACE MAKER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29605 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY DXY ST. JUDE MEDICAL, INC., CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention