BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR

    MDR report key: 4191751 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04769
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    July 18, 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
    CA, 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. COMPLAINT COULD NOT BE CONFIRMED. THE REASON FOR THE REPORTED INTERMITTENT CAPTURE, NOISE, AND OUTPUT ANOMALY COULD NOT BE DETERMINED. NORMAL ELECTRICAL CHARACTERISTICS AND DEVICE FUNCTION WERE MEASURED THROUGH ALL MECHANICAL, ELECTRICAL, AND THERMAL STRESS TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED NOISE, INTERMITTENT CAPTURE, AND AN OUTPUT ANOMALY. THE DEVICE WAS EXPLANTED, REPLACED, AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29892 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY DXY ST. JUDE MEDICAL, INC., CRMD PM2110

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention 1688TC/52, (B)(4)