BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 1896625 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05378
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 21, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS ALSO NOTED THAT THE LEAD EXHIBITED CAPTURE THRESHOLDS OF 4.25 V, 0.5 MS IN THE BIPOLAR CONFIGURATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A (B)(6) . THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention (B)(4)