BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 5376875 · Received February 15, 2005

    Report

    Report Number
    5376875
    Event Type
    Injury
    Date Received
    February 15, 2005
    Date of Event
    November 18, 2004
    Report Date
    December 22, 2004
    Manufacturer
    MEDTRONIC INC. USA
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    DEPLETED BATTERY ON DRUG ADMINISTRATION PUMP USED TO TREAT CHRONIC CERVICAL PAIN. REPLACEMENT OF SYNCHRO MED EL PUMP WITH SYNCHRO MED II PUMP THEN CONNECTED TO THE EXISTING INTRATHECAL CATHETER. MFR #6000030-2005-00310.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SYNCHRO MED EL DRUG ADMINISTRATION SYSTEM LKK MEDTRONIC INC. USA SYNCHRO MED EL PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention