BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 772811 · Received October 23, 2006

    Report

    Report Number
    2182207-2006-01762
    Event Type
    Injury
    Date Received
    October 23, 2006
    Report Date
    September 20, 2006
    Manufacturer
    NEUROLOGICAL DIV; MEDTRONIC, INC.
    Product Code
    LKK
    PMA / PMN Number
    p860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MFR'S REP REPORTED THAT THE PUMP WAS REMOVED DUE TO INFECTION. THE HCP TRACKED THE INFECTION BACK TO THE CATHETER. THE PT WAS RECEIVING COMPOUNDED BACLOFEN 750 MCG/ML AT 127 MCG/DAY. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE TO US. SAME AS MFR'S REPORT #: 6000030-2006-01763.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R EXPLANTED:| IMPLANTED:| CATHETER MODEL 8709AA, LOT # J11785R06