BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX DR

    MDR report key: 1073265 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02064
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 22, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WAS IN BACK-UP MODE. AN ATTEMPT TO PERFORM A DOWNLOAD FAILED. THE PULSE GENERATOR HAD NOT REACHED ELECTIVE REPLACEMENT INDICATOR (ERI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY ADX DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5380 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention