BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY DR

    MDR report key: 1073395 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02184
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 28, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE PULSE GENERATOR TO EXHIBIT BACK-UP MODE AND TELEMETRY ANOMALY DUE TO A DISCREPANT INTEGRATED CIRCUIT. AFTER REPLACING THE INTEGRATED CIRCUIT, NORMAL FUNCTION ENSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO TESTING OR PROGRAMMING COULD BE PERFORMED WITH THE PULSE GENERATOR. A SOFTWARE DOWNLOAD WAS PERFORMED, AFTER WHICH THE DEVICE EXHIBITED BACKUP VVI MODE WITH NO TELEMETRY. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMMETRY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5360 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention