BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 1131583 · Received August 11, 2008

    Report

    Report Number
    1131583
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 17, 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

    SURGEON NOTES DIFFICULTY REFILLING PUMP. MEDICATION FOUND TO BE "CLOUDY" WHEN PUMP CHANGED OUT. THE TWO RECENT REFILLS HAVE BEEN DIFFICULT, AND THERE HAVE BEEN REPORTS OF CLOUDY PRECIPITATE IN THE MEDICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR