BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY ADX DR

    MDR report key: 1896695 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05282
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 24, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH WHICH STATED "OLYMPUS LIGHT SOURCE FOR EGD (ESOPHAGO-GASTRODUODENOSTOMY) TUBE PLACEMENT WITH MD. BULB BURNED OUT - SWITCHED TO SPARE BULB ON MACHINE WHICH IS NOT ADEQUATE LIGHT FOR A PROCEDURE. SWITCHED TO ALTERNATE LIGHT SOURCE WHICH ITSELF HAS NOISE AND LOW LIGHT. PHYSICIAN WAS UNABLE TO COMPLETE PROCEDURE WITH EITHER PIECE OF EQUIPMENT. PROCEDURE TERMINATED. ALL THIS OCCURRED DURING THE PROCEDURE".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO ELECTROGRAM WERE PRESENT DURING DEVICE INTERROGATION. THE PULSE GENERATOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY ADX DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5360

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Required Intervention