BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 2061437 · Received April 7, 2011

    Report

    Report Number
    2061437
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDTRONIC NEUROLOGY
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    INFUSION PUMP MALFUNCTIONED. PER SALES REP, PUMP FAILED PREMATURELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED PUMP, INFUSION LKK MEDTRONIC NEUROLOGY 8637-20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR