BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY SR

    MDR report key: 1223825 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03459
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 30, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMAP880086
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NON-PACEMAKER DEPENDENT PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER AN ACCIDENT. THE PULSE GENERATOR COULD NOT BE INTERROGATED. THE ID BYTE WAS CHECKED AND WAS NOT CORRECT; ONCE IT WAS RESTORED THE DEVICE WAS FOUND TO BE IN BACKUP VVI. DUE TO A FAILED DOWNLOAD AND INABILITY TO COMMUNICATE WITH THE DEVICE, FURTHER TROUBLESHOOTING COULD NOT BE PERFORMED. IT WAS NOTED THAT THE PATIENT HAD BEEN CARDIOVERTED RECENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5172 NA

    Patients

    Seq Age Sex Outcome Treatment
    1