BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY XL DR

    MDR report key: 1223347 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03231
    Event Type
    Injury
    Date Received
    November 10, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z2977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED A LONGEVITY OF LESS THAN 3 MONTHS WITH MEASUREMENTS OF 2.76 V, 8 UA, 98.5 MAGNET RATE AND BATTERY IMPEDANCE OF 28 KOHMS. SOFTWARE WAS UPGRADED, BUT THE PROBLEM PERSISTED. MEASURED DATA SHOWED LESS THAN 1 KOHM IMPEDANCE. REINTERROGATION SHOWED THE SAME RESULTS. THE DEVICE WAS EXPLANTED.

    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 Required Intervention