BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX DR

    MDR report key: 1073288 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02087
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 7, 2008
    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
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE PULSE GENERATOR TO BE IN BACK-UP MODE DUE TO MULTIPLE FLIPPED BITS. THE DEVICE FAILED TO DOWNLOAD DUE TO THE BATTERY WAS AT END OF LIFE (EOL). AFTER REPLACING THE BATTERY AND DOWNLOADING THE PRODUCT CODE THE DEVICE FUNCTIONED NORMALLY.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH THE PULSE GENERATOR IN BACK-UP MODE. SEVERAL ATTEMPTS TO PERFORM A DOWNLOAD FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY ADX DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5380 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention