BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3142892 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08550
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANLAYSIS OF THE CATHETER REVEALED CATHETER BODY DEFORMED IN SHAPE. ONLY THE DISTAL PORTION OF THIS MODEL WAS RECEIVED. OTHER THAN SEVERAL SLIGHT AREAS OF ELECTROCAUTERY DAMAGE, NO ANOMALIES WERE NOTED WITH THIS SEGMENT. IT PASSED ALL TESTING. THE UNUSUAL AMOUNT OF BENDING SEEN RELATES TO THE CATHETER MIGRATING OUT OF THE INTRATHECAL SPACE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER HAD MIGRATED/DISLODGED. THE PATIENT EXPERIENCED INCREASED CLONUS AND LESS THAN 50 % THERAPY RELIEF. AN X-RAY WAS PERFORMED AND THE CATHETER APPEARED COILED AROUND L4-L5. THE HCP WAS DECREASING THE DOSE OF BACLOFEN AND THEN THE PATIENT PLANNED TO SEE THE SURGEON FOR CATHETER REVISION/REPLACEMENT. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY, NO ADVERSE EVENT. THE PUMP WAS USED TO DELIVER LIORESAL. IT WAS LATER REPORTED THE CATHETER WAS REVISED (B)(6) 2013. THE SPINAL SEGMENT HAD MIGRATED OUT OF THE INTRATHECAL SPACE. A NEW SPINAL SEGMENT WAS REPLACED BACK INTO THE THE INTRATHECAL SPACE AND CONNECTED TO THE REMAINING EXISTING CATHETER AFTER TRIMMING THE OLD PORTION OF THE SPINAL SEGMENT. THE PATIENT WAS STARTED ON 100 MCG/DAY WITH LIORESAL, 2000 MCG/ML, 20 ML. THE PATIENT HAD NOT YET ACHIEVED EFFECTIVE THERAPY AND WOULD BE TITRATED BY THE MANAGING HCP. THE PATIENT OUTCOME WAS INDICATED AS ¿DOING FINE¿ BUT HAD INCREASED SPASTICITY AND CLONUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243688 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention