BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1081347 · Received July 24, 2008

    Report

    Report Number
    6000030-2008-04285
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    RICE CREEK MANUFACTRING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USED FOR CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED UNSPECIFIED WITHDRAWAL-TYPE SYMPTOMS. A CATHETER REVISION WAS PERFORMED DUE TO A LEAK. DATES OF THE EVENT, REVISION, AND CONCENTRATION AND DAILY DOSE OF BACLOFEN WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED| IMPLANTED| CATHETER MODEL 8711 LOT# J11406R09