BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1924813 · Received December 7, 2010

    Report

    Report Number
    3007566237-2010-10258
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    September 14, 1999
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT REC'D 18ML OF BACLOFEN INJECTED SUBCUTANEOUSLY. THIRTY MINUTES LATER, THERE WERE NO ADVERSE EFFECTS TO THE PT. IT WAS RECOMMENDED THAT THE PT BE OBSERVED FOR THE REMAINDER OF THE DAY AND EMERGENCY PROCEDURES BE READILY AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED. FURTHER F/U IS NOT POSSIBLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention