BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL DR

    MDR report key: 1896387 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05344
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 17, 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

    FINAL ANALYSIS FOUND THE PULSE GENERATOR TO BE IN BACK-UP MODE DUE TO DEVICE BATTERY VOLTAGE DROPPING BELOW END-OF-LIFE (EOL) LEVEL. THIS WAS DUE TO NORMAL BATTERY DEPLETION. AFTER REPLACING THE BATTERY, NORMAL FUNCTION ENSUED.

    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

    IT WAS REPORTED THAT THE SYMPTOMATIC PATIENT PRESENTED TO THE EMERGENCY ROOM IN BACKUP VVI MODE. THE PATIENT ALSO EXPERIENCE SYNCOPE AND WAS LOST TO FOLLOW-UP WITH NO PRIOR INTERROGATIONS ON THE DEVICE. THERE WAS NO PACING SUPPORT UNTIL DOWNLOAD ATTEMPT. DUE TO LOW BATTERY STATUS FURTHER TROUBLESHOOTING COULD NOT BE PERFORMED. THE PULSE GENERATOR WAS REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI).

    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".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5826

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention