BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 699581 · Received April 11, 2006

    Report

    Report Number
    2182207-2006-00578
    Event Type
    Injury
    Date Received
    April 11, 2006
    Date of Event
    March 13, 2006
    Report Date
    April 10, 2006
    Manufacturer
    MEDTRONIC, INC, NEUROLOGICAL DIVISION
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PATIENT EXPERIENCED "WITHDRAWAL". DATE OF ONSET OF THE REPORTED EVENT WAS 3/13/2006. THE PATIENT WAS RECEIVING FENTANYL; THE RATE OF INFUSION OF VIA THE PUMP WAS INCREASED. NO DEVICE TROUBLESHOOTING WAS PERFORMED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP LKK MEDTRONIC, INC, NEUROLOGICAL DIVISION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention