BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1062925 · Received June 19, 2008

    Report

    Report Number
    6000030-2008-03316
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 25, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0956-2008
    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 THE PT WAS FOUND UNCONSCIOUS WITH A BODY TEMPERATURE OF 94 DEGREES FAHRENHEIT. THE PHYSICIAN WAS QUESTIONING PUMP FUNCTIONING. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING DELIVERED VIA THE PUMP WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED:| CATHETER MODEL 8711 LOT# J11509R68| EXPLANTED: