BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRATHECAL PUMP - SYNCHROMED II PUMP

    MDR report key: 1182083 · Received September 19, 2008

    Report

    Report Number
    1182083
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    July 2, 2008
    Report Date
    September 19, 2008
    Manufacturer
    MEDTRONIC NEUROLOGICAL
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH INTRATHECAL PUMP. OUTSIDE MEDICATION PROVIDER UNABLE TO REFILL PUMP. PATIENT TO NEUROSURGERY CLINIC. UNABLE TO REFILL PUMP. PATIENT TO OR FOR REPLACEMENT OF PUMP AND NEW MEDICATION. PUMP WAS FOUND TO BE PLUGGED. MEDICATION FROM OUTSIDE COMPANY NOTED TO BE CLOUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRATHECAL PUMP - SYNCHROMED II PUMP PUMP, INTRATHECAL LKK MEDTRONIC NEUROLOGICAL 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR