BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1123815 · Received August 15, 2008

    Report

    Report Number
    6000030-2008-04983
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS REPLACED TO AVOID IN-VIVO BATTERY DEPLETION. THE PUMP WAS DISPOSED OF BY THE HOSPITAL PER INTUITIONAL POLICY. THE DRUG IN THE PUMP WAS LIORESAL AT A CONCENTRATION OF 2000 MCG/ML AND DOSE OF 1000 MCG/DAY. THE CATHETER WAS REPLACED DUE TO A FRACTURE AT THE BACK INCISION SITE AND A PARTIAL FRACTURE AT THE SUTURE TIE ON THE LIP OF THE CATHETER CONNECTOR SITE. THE INTRATHECAL CATHETER REMAINED IN THE PATIENT SO ONLY THE PARTIAL PROXIMAL END AND THE CONNECTOR WERE EXPLANTED. A NEW CATHETER WAS PLACED. THE INFUSION OF LIORESAL WAS RE-STARTED AT 150 MCG/DAY AT A CONCENTRATION OF 2000 MCG/ML. NO SYMPTOMS OR FURTHER OUTCOME WERE REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

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