BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1250391 · Received December 3, 2008

    Report

    Report Number
    2182207-2008-07996
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 18, 2008
    Report Date
    November 10, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE CAREGIVER REPORTED A LEAKY CATHETER. THE SPINE SITE WAS OPENED AND THE CATHETER WAS NOTED TO BE COILED UP SUBCUTANEOUS (OUT OF THE INTRATHECAL SPACE). THE CATHETER WAS REPLACED. THERE WAS NO IRIDIUM TIP AT THE END OF THE CATHETER. THE CATHETER LENGTH MEASURED AND WAS EQUAL TO WHAT WAS ORIGINALLY IMPLANTED. THE PATIENT REPORTEDLY RECOVERED WITHOUT SEQUELAE. THE MEDICATION USED WAS COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention CATHETER: MODEL 8709| EXPLANTED:| PROGRAMMER: MODEL 8840| EXPLANTED: