BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY DR

    MDR report key: 1223841 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03445
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 23, 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 Location
    IN
    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 COULD NOT BE INTERROGATED. ALL ATTEMPTS AT TELEMETRY TESTING WERE UNSUCCESSFUL. THERE WAS NO MAGNET RESPONSE AND THE PATIENT WAS IN INTRINSIC RHYTHM. 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