BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 1896554 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05376
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 30, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. RELIABILITY LABORATORY TECHNICIAN, (B)(4) - FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND RF TELEMETRY WAS INTERMITTENT. THE PULSE GENERATOR WAS CUT OPEN AND VISUALLY INSPECTED. CRACKS WERE NOTED ON BOTH OF THE RF MODULE CRYSTAL SOLDER JOINTS.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    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