BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1230544 · Received November 13, 2008

    Report

    Report Number
    6000030-2008-07421
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    February 1, 2002
    Report Date
    October 14, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE PUMP AND CATHETER EXPLANTED IN 2002, BECAUSE OF AN ABDOMINAL WOUND INFECTION. THE PATIENT EXPERIENCED EROSION, INFECTION, AND FEVER ASSOCIATED WITH THE EVENT. THE DAILY DOSE OF LIORESAL 500 MCG/ML BEING DELIVERED VIA PUMP WAS NOT KNOWN. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL 8709| PROGRAMMER: MODEL PROGRAMMER| EXPLANTED:| IMPLANTED: