BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1222424 · Received November 5, 2008

    Report

    Report Number
    3004209178-2008-07222
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BRIDGE BOLUS WAS NOT PERFORMED AND THE PATIENT WAS BEING OVERDOSED. THE PUMP WAS REFILLED APPROXIMATELY 48 HRS PRIOR TO THE REPORT. THE VOLUME OF BACLOFEN 500 MCG/ML DELIVERED WAS 1.1598 ML. ALL THE OLD DRUG WAS INFUSED AND THE PATIENT WAS RECEIVING 2000MCG/ML ITB AT THE ORIGINAL 500MCG/ML FLOW RATE. THE HCP WENT TO THE PATIENT'S HOME TO UPDATE THE PUMP TO THE CORRECT DOSING. THE PATIENT HAD FALLEN AND WAS LETHARGIC OVER THE PAST 24 HOURS BUT WAS DOING WELL NOW ACCORDING TO THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8711 LOT# N147617002| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN| IMPLANTED: