BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1192077 · Received October 7, 2008

    Report

    Report Number
    6000030-2008-06366
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    July 22, 2008
    Report Date
    September 10, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A 58.3 CENTIMETER PROXIMAL SEGMENT WAS RETURNED FOR ANALYSIS. THE FINAL ANALYSIS REVEALED ACCEPTABLE CATHETER TESTING. THE PUMP WAS ALSO RETURNED, AND ANALYSIS REVEALED NO ANOMALY FOUND. NORMAL DEVICE FUNCTION. RESULTS CODE USED FOR THE CATHETER. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT PLACEMENT OF A NEW PUMP. THE PUMP WAS REPLACED IN 2008, DUE TO "NEAR" END OF BATTERY LIFE; THE CATHETER WAS ALSO REPLACED AT THAT TIME. THE PT HAD A CEREBROSPINAL FLUID LEAK FROM THE OLD PUMP. THE PT EXPERIENCED INCREASED SPASTICITY FROM THE OLD PUMP AND POST-OPERATIVELY SPASTICITY FOLLOWING PLACEMENT OF A NEW PUMP. THE PT OUTCOME WAS REPORTED AS "NO INJURY".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER MODEL 8709| PROGRAMMER MODEL PROGRAMMER