BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 383038 · Received March 13, 2002

    Report

    Report Number
    6000030-2002-00161
    Event Type
    Malfunction
    Date Received
    March 13, 2002
    Date of Event
    January 25, 2002
    Report Date
    February 14, 2002
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM FOREIGN REPORTER THAT PATIENT EXPERIENCED SYMTPOMS OF OVERINFUSION TWO HOURS AFTER PUMP REPLACEMENT. PATIENT EXPERIENCED COMA FOR 2 DAYS - RECEIVING BACLOFEN IN THE INTRATHECAL PUMP. PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL IMPLANTABLE INFUSION PUMP LKK MEDTRONIC INC. 862618 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization