BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3831931 · Received April 14, 2014

    Report

    Report Number
    3831931
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS RECENTLY EVALUATED BY A PROVIDER FOR ISSUES RELATED TO A PUMP AND CONCERN FOR RECENT BACLOFEN WITHDRAWAL AND INCREASED SPASTICITY. THE PATIENT HAD IMAGING STUDIES THAT DID NOT DEMONSTRATE ANY DISCONTINUITY DUE TO THE BACLOFEN PUMP OR SYSTEM; HOWEVER, THERE WAS STILL CONCERN THAT PATIENT HAS BEEN SYMPTOMATIC, AND THERE WERE NO OTHER ISSUES AFTER INTERROGATION OF THE SYSTEM. PUMP WAS REMOVED EARLIER THIS YEAR IN THE OPERATING ROOM: REVISION OF INTRATHECAL BACLOFEN PUMP. THERE WAS SOME FLUID THAT WAS NOTED AROUND THE POCKET SITE. ON EVALUATION OF THE PUMP, THERE WAS DEBRIS NOTED AT THE PROXIMAL END OF THE CATHETER AND INSIDE OF THE PUMP AS WELL. AS SUCH, THERE WAS CONCERN THAT THIS MIGHT HAVE BEEN WHAT WAS CAUSING SOME POSSIBLE FAILURE. OF NOTE, THERE WAS DISTAL CEREBROSPINAL FLUID (CSF) FLOW THAT WAS OCCURRING SPONTANEOUSLY COMING OUT OF THE CATHETER, AND AFTER THE PUMP POCKET FLUSHED. SURGEON & TEAM WERE ABLE TO SEE FLUID COME OUT OF THE DISTAL END. AS SUCH, THE DECISION WAS MADE, DUE TO THE AMOUNT OF DEBRIS NOTED AT THE PUMP SITE, TO IMPLANT A NEW MEDTRONIC SYNCHROMED II PUMP, MODEL #8637-40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227742 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC 8637-40 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR