BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2901337 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-00293
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 12, 2012
    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
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8731SC, SERIAL#: UNKNOWN, IMPLANTED: (B)(6) 2009, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS AND "SEEMED TO NOT HAVE ANY EFFECT OF PUMP AND CATHETER"; PATIENT ALSO EXPERIENCED ALTERED MENTAL STATUS AND INCREASED SPASTICITY. "AN X-RAY OF THE SYSTEM AND DRUG DELIVERY SEEMED TO BE OK". THE LIQUID WAS ASPIRATED FROM THE PUMP; IT WAS REFILLED AND REPROGRAMMED TO GIVE THE PATIENT A BOLUS OF 100 MCG. THERE WERE NO VOLUME DISCREPANCIES WHEN ASPIRATING AND DOING A REFILL. HOWEVER THE PATIENT DID NOT HAVE ANY EFFECT AFTER BEING GIVEN THE BOLUS. THE PATIENT WAS VERY SICK AND THE NEUROSURGEON WAS UNSURE WHETHER OR NOT THE PATIENT WAS CAPABLE OF HANDLING AN OPERATION TO MAKE A CATHETER/PUMP REVISION. THE PUMP WAS INTERROGATED AND SHOWED NO MESSAGES THAT COULD INDICATE MALFUNCTION. DRUG DELIVERED VIA THE DEVICE WAS LIORESAL. IT WAS LATER REPORTED THAT ON (B)(6) 2012, THE NEUROSURGEON OPENED THE BACK OF THE PATIENT AND SAW THAT CSF (CEREBROSPINAL FLUID) LEAKAGE CAME FROM THE CONNECTOR BETWEEN THE DISTAL AND PROXIMAL PART OF THE CATHETER. THE NEUROSURGEON CUT OF A PART OF THE DISTAL CATHETER AND CONNECTED THE TWO PARTS AGAIN. FOLLOWING THIS OPERATION THE PATIENT WAS NOTED TO BE "FINE AGAIN AND THE THERAPY WAS FUNCTIONING GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10128 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Hospitalization| R