BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1230002 · Received November 12, 2008

    Report

    Report Number
    6000030-2008-07391
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 13, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SPINAL RODS PLACED WHICH RESULTED IN INFECTION OF SPINAL RODS AND PUMP. THE PUMP WAS REMOVED; THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP CONTAINED BACLOFEN 2000 MCG/ML AT A DOSE OF 260.2 MCG/ML IN COMPLEX CONTINUOUS DOSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8626 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention PROGRAMMER: MODEL PROGRAMMER| IMPLANTED:| CATHETER: MODEL 8711| EXPLANTED: