BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRHOMED II

    MDR report key: 1090623 · Received August 1, 2008

    Report

    Report Number
    2182207-2008-04590
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    May 1, 2008
    Report Date
    July 23, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS REQUIRED INCREASING DOSAGE WITHOUT A RESPONSE TO THE MEDICATION. THIS WAS NOTED FOLLOWING A PUMP REPLACEMENT IN 2008. THE INITIAL BACLOFEN DOSE WAS 96 MCG/DAY WITH SUBSEQUENT INCREASES TO 320 MCG/DAY. ON TWO DAYS LATER, THE HCP PERFORMED X-RAYS AND EVERYTHING LOOKED FINE. THE HCP THEN PERFORMED A BACLOFEN ASSAY LEVEL. THE RESULT CAME BACK AS ZERO MEDICATION IN THE CEREBROSPINAL FLUID. NO ISSUES WERE NOTED WHEN THE RESIDUAL VOLUME WAS ASPIRATED FROM THE PUMP. THE PATIENT WAS TAKEN TO SURGERY FOR A CATHETER REVISION ON TWO MONTHS LATER. WHEN THE CATHETER WAS DISCONNECTED FROM THE PUMP A BRISK FLOW OF CSF FROM CATHETER WAS SEEN. A BRISK FLOW OF CSF WAS ALSO SEEN WHEN THE CATHETER WAS DISCONNECTED FROM THE SPINAL INCISION SITE. THE PROXIMAL SEGMENT OF THE CATHETER WAS REPLACED; THE PUMP WAS THEN RESTARTED AT AN INITIAL DOSE OF 96 UG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRHOMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| CATHETER MODEL 8703W LOT# L42928| IMPLANTED,| PROGRAMMER MODEL 8840 LOT# UNKNOWN