BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY SR

    MDR report key: 1073249 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-01963
    Event Type
    Injury
    Date Received
    July 11, 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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THAT THE DEVICE AS RECEIVED COULD NOT BE INTERROGATED. THE WARNING MESSAGE "INSTALLED SOFTWARE DOES NOT SUPPORT THIS PULSE GENERATOR. EMERGENCY VVI PROGRAMMING IS AVAILABLE" WAS DISPLAYED ON THE PROGRAMMER SCREEN. THE WARNING MESSAGE APPEARED DUE TO AN UNDEFINED VALUE OF THE MODEL NUMBER. THE MODEL NUMBER WAS RESTORED AND THE DEVICE THEN WORKED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW UP THE PROGRAMMER REQUESTED THE USER TO DOWNLOAD NEW FIRMWARE TO THE PACEMAKER DUE TO AN ANOMALY.THE DOWNLOAD WAS ATTEMPTED BUT COULD NOT BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5142 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention