BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 1896680 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05394
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 3, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    THE PULSE GENERATOR WOULD INTERMITTENTLY NOT PROVIDE BACKUP PULSES DURING A RIGHT VENTRICULAR AUTOCAPTURE TEST. THE TEST WAS SET UP WITH A PRIMARY UNIPOLAR PULSE AND BIPOLAR BACKUP PULSE. THE TEST WOULD DECREMENT DOWN PROVIDING BACK- UP PULSES AS DESIGNED, BUT WITHOUT REASON STOPPED PROVIDING THEM WHEN THERE WAS NO CAPTURE EVIDENT ON THE ELECTROGRAMS. A SIMILAR TEST WITH BIPOLAR PRIMARY AND SECONDARY PULSES WAS COMPLETED WITHOUT ISSUE. AUTOCAPTURE WAS TURNED OFF.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR