BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1030848 · Received April 17, 2008

    Report

    Report Number
    6000030-2008-02048
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    January 1, 2007
    Report Date
    March 19, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0950-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED MOTOR GEAR SHAFT WEAR AND MOTOR STALL. THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR SYNCHROMED EL PUMP MOTOR STALL DUE TO GEAR SHAFT WEAR MANUFACTURED BEGINNING SEPT 1999.

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PT WAS HAVING INCREASED SPASTICITY. A CATHETER DYE STUDY WAS DONE (DATE UNK) RESULTING IN THE DIAGNOSIS OF "CATHETER FAILURE"; THE CATHETER WAS REPLACED. THE PUMP WAS ALSO REPLACED AT THE TIME OF THE CATHETER REPLACEMENT BASED ON AGE OF DEVICE AND HCP JUDGEMENT. THE PT WAS REPORTED TO BE DOING WELL AND THAT HIS SPASTICITY IS UNDER CONTROL. THE PUMP AND THE CATHETER WERE USED TO DELIVER COMPOUNDED BACLOFEN 2000 MCG/ML AT 300 MCG/ML DAY. PLEASE SEE MFR'S REPORT # 600003020080392.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANTED:| PROGRAMMER MODEL PROGRAMMER| EXPLANTED:| CATHETER MODEL # 8711| EXPLANTED: