BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 4191759 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04569
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 15, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. EVALUATION: THE REPORTED FIELD EVENT OF A STRIPPED SETSCREW WAS CONFIRMED IN THE LABORATORY VIA DESTRUCTIVE ANALYSIS OF THE SETSCREW. THE DEVICE WAS TESTED ON THE BENCH AND THE THREADS OF THE V-TIP CONNECTOR BLOCK AND THE SETSCREW. THE DEVICE WAS TESTED ON THE BENCH AND THE THREADS OF THE V-TIP CONNECTOR BLOCK AND THE SETSCREW WERE FOUND TO BE DAMAGED. THE CAUSE OF THE SETSCREW DAMAGE COULD BE DETERMINED. THE REPORTED FILED EVENT OF INTERMITTENT CAPTURE WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A STRIPPED SETSCREW AND EXHIBITED INTERMITTENT CAPTURE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29080 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention