BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 3003817 · Received February 15, 2013

    Report

    Report Number
    3003817
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    PATIENT REFERRED FROM OUTSIDE PROVIDER AND PER PATIENT WISHES TO HAVE THE PUMP EXPLANTED. IT WAS REPORTED THAT WHEN THE OUTSIDE PROVIDER ASPIRATED PUMP WITH REFILL PROCEDURE, BROWNISH FLUID ASPIRATED. PATIENT HAS BEEN ON COUMADIN IN THE PAST. AFTER DISCUSSION, PATIENT FELT LITTLE RELIEF FROM SPASTICITY WITH PUMP. REQUESTED THE PUMP BE REMOVED. PUMP BELIEVED TO BE AT ONE YEAR IN USE. FEBRUARY 2012 MEDICAL RECORD ENTRY: "THE PREVIOUS PUMP PT'S BACLOFEN PUMP WAS PLACED 7 YRS AGO AND UPON INTERROGATION, SHOWS A DEPLETED BATTERY."PUMP WAS NOT ACCESSED DURING EXPLANTATION. PHYSICIAN DOES NOT KNOW IF "BROWN FLUID" STILL PRESENT IN THE PUMP.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66562 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR