BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1051106 · Received May 22, 2008

    Report

    Report Number
    2182207-2008-02736
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND PRESENTED TO THE EMERGENCY ROOM WITH A POSSIBLE OVERDOSE. IT WAS BELIEVED THAT THE PUMP MAY HAVE BEEN AT TOO HIGH OF A FLOW RATE. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 8840 LOT# UNK| CATHETER MODEL 8711 LOT# J12094R31| IMPLANTED:| EXPLANTED: