BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1033309 · Received March 3, 2008

    Report

    Report Number
    2182207-2008-01034
    Event Type
    Injury
    Date Received
    March 3, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 1, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE HCP REPORTED, THAT ABOUT 1 HOUR AFTER A PUMP REFILL WITH 20 ML OF MORPHINE 10 MG/ML, THE PATIENT WAS FOUND IN THE PARKING LOT WITH ALTERED MENTAL STATUS, COGNITIVE SYMPTOMS, RESPIRATORY PROBLEMS AND SOMNOLENCE. PARAMEDICS WERE CALLED AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE HE WAS GIVEN NARCAN, AFTER WHICH HE 'PERKED UP'. THE PATIENT WAS PUT ON A NARCAN INTRAVENOUS DRIP. AT THE HOSPITAL, 2 MLS WERE ASPIRATED FROM THE PUMP RESERVOIR; THE EXPECTED VOLUME WAS 20 MLS. PUMP PROGRAMMING WAS VERIFIED AS CORRECT; THE HCP REPORTED, THAT THE REFILL VOLUME WAS INJECTED SUBCUTANEOUSLY RATHER THAN INTO THE PUMP. THE HCP REPORTED THE PATIENT OUTCOME AS 'NO INJURY.'

    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| R CATHETER MODEL 8711 LOT# N101575017| PROGRAMMER MODEL 8840 LOT# UNKNOWN| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: