BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY DR

    MDR report key: 1223803 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03207
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    July 9, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z2977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT MULTIPLE BITS WERE FLIPPED CAUSING THE DEVICE TO BE IN BACKUP VVI MODE. THE PRODUCT CODE WAS SUCCESSFULLY DOWNLOADED IN THE FIELD, AND THE DEVICE EXHIBITED ELECTIVE REPLACEMENT INDICATOR (ERI) CHARACTERISTICS. BACKUP OPERATION DID NOT RECUR DURING TESTING. THE REPORTED BATTERY DEPLETION COULD NOT BE EXPLAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED BACKUP VVI MODE IN 2008. A SOFTWARE DOWNLOAD WAS PERFORMED, AND THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). ON SIX DAYS EARLIER, THE DEVICE SHOWED TWO YEARS REMAINING LONGEVITY. THE DEVICE WAS REPLACED.

    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 Required Intervention