BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY DR

    MDR report key: 1073386 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02175
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    June 2, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMAP880086
    Removal / Correction Number
    Z2977
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE PULSE GENERATOR TO BE IN BACK-UP MODE. THE PRODUCT CODE COULD NOT BE DOWNLOADED DUE TO BATTERY VOLTAGE AT END-OF-LIFE (EOL). AFTER REPLACING THE BATTERY AND DOWNLOADING THE PRODUCT CODE THE DEVICE FUNCTIONED NORMALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYMPTOMATIC PATIENT PRESENTED FOR A FOLLOW-UP WITH HER DEVICE IN BACKUP VVI MODE. A USER DOWNLOAD DID NOT RESTORE THE DEVICE. THE HARDWARE ELECTIVE REPLACEMENT INDICATOR (ERI) BYTE WAS CHECKED, AND AN "OPERATION FAILED" MESSAGE WAS DISPLAYED. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS AT COMMUNICATING WITH THE DEVICE, IT WAS DETERMINED THAT FURTHER TROUBLESHOOTING COULD NOT BE PERFORMED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5370 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention