BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1211058 · Received October 24, 2008

    Report

    Report Number
    2182207-2008-06867
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 1, 2007
    Report Date
    September 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ON A TRIP IN THE MOUNTAINS AT HIGH ALTITUDES, THE PT WAS AIRLIFTED TO THE HOSP IN 2007. SHE EXPERIENCED UNCONSCIOUSNESS, STOPPED BREATHING AND WAS PLACED ON A VENTILATOR. THE PT WAS PLACED IN THE INTENSIVE CARE UNIT, AND "JUST WOKE UP ONE DAY". THE PUMP CONTAINED MORPHINE. NO OTHER INFO WAS PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R IMPLANTED| CATHETER MODEL 8709| EXPLANTED| PROGRAMMER MODEL 8840