BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY DR

    MDR report key: 1073415 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02199
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 9, 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 EXHIBITED LOSS OF TELEMETRY DUE TO LOW BATTERY VOLTAGE. THE PACEMAKER WAS RECEIVED IN BACKUP MODE BECAUSE MULTIPLE BITS WERE FLIPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WAS IMPOSSIBLE TO INTERROGATE AND WAS FOUND IN BACKUP VVI MODE.

    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