BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED PUMP

    MDR report key: 307320 · Received November 29, 2000

    Report

    Report Number
    307320
    Event Type
    Injury
    Date Received
    November 29, 2000
    Date of Event
    July 5, 2000
    Report Date
    September 7, 2000
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO CLINIC FOR PUMP FILL AND REPROGRAMMING. PROGRAM WAS CHANGED FROM "SIMPLE CONTINUOUS" TO "COMPLEX" PROGRAM WITH AN INCREASE OVERALL DOSE 20% 1400-2300. CALCULATIONS WERE MADE AND PT'S DOSE WAS DOUBLED ACCIDENTALLY. THE TOTAL MG/DAY SHOWED 4.400 MCG UP FROM 2.0 MCG/D. THE PROGRAM WAS CHECKED BUT THE ERROR WAS NOT FOUND UNTIL 2 DAYS LATER WHEN THE PT PRESENTED TO THE CLINIC FEELING NAUSEATED AND DROWSY. THE PT WAS HOSPITALIZED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED PUMP INTRATHECAL INFUSION PUMP LKK MEDTRONIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention