BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITY XL DR

    MDR report key: 1223834 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03448
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 11, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z2977
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WAS IN BACKUP VVI. THE PATIENT'S PRESENTING INTRINSIC RHYTHM WAS FASTER THAN 67.5 PULSES PER MINUTE. DUE TO TELEMETRY CORRUPTION, FURTHER TROUBLESHOOTING COULD NOT BE PERFORMED. DEVICE REPLACEMENT WAS TO BE SCHEDULED DUE TO UNRESOLVED BACKUP VVI STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5376 NA

    Patients

    Seq Age Sex Outcome Treatment
    1