BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3030099 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04455
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 4, 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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN NOTICING A CHANGE IN EFFICACY IN (B)(6) 2012. THE PATIENT NOTED INCREASED TOE WALKING, INCREASED CLONUS, AND INCREASED SPASMS; ALTHOUGH, NOT AS SEVERE AS BASELINE PRIOR TO PUMP PLACEMENT. IN JANUARY, THE PUMP DOSE WAS INCREASED, AND A 50 MCG TEST BOLUS WAS DELIVERED. IT WAS NOTED THE PATIENT HAD AN IMMEDIATE RESPONSE; HOWEVER, THAT RESPONSE WANED AFTER HOURS. AN X-RAY WAS PERFORMED ON (B)(6) 2013 AND REVEALED A CATHETER FRACTURE IN THE SPINAL SEGMENT JUST BEFORE THE ANCHOR. THE PATIENT WAS SUPPLEMENTED WITH ORAL BACLOFEN 10 MG, THREE TIMES PER DAY. THE PATIENT'S SYMPTOMS ALSO INCLUDED INCREASED SPASTICITY WITH LEG SYMPTOMS, AND SUBOPTIMAL RESPONSE TO INTRATHECAL BACLOFEN, IMPACTING FUNCTION AND FATIGUE. THE PATIENT REQUIRED HOSPITALIZATION. A SURGICAL REVISION WAS PERFORMED AND THE SURGEON CONFIRMED A COMPLETE BREAK, BUT WAS ALSO UNABLE TO ASPIRATE CEREBROSPINAL FLUID (CSF) FROM THE SPINAL SEGMENT. THE SPINAL SEGMENT WAS REPLACED AND THE PATIENT WAS RESTARTED ON THE SAME DOSE, WITH WEANING OF THEIR ORAL MEDICATION PLANNED. THE PATIENT WAS HOME AND STABLE, BUT THEY WERE STILL TRYING TO FIND THE RIGHT DOSE. THEY WERE TITRATING DOWNWARD, AS THE POST-OPERATIVE DOSE PROVED TO BE TOO HIGH AS THE PATIENT WAS TOO HYPOTONIC. THE PUMP WAS BEING USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133984 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Hospitalization| R