BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1843335 · Received September 22, 2010

    Report

    Report Number
    6000030-2010-07173
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Report Date
    August 23, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, PT NEVER HAD THERAPEUTIC EFFECT SINCE HAVING FENTANYL IN THE PUMP. PT STATED IT WAS ABOUT 2-3 YEARS AGO THAT THEY STARTED PUTTING FENTANYL IN THE PUMP. THE PT WAS CURRENTLY TAKING ORAL MEDS AND STATED THAT WAS THE ONLY WAY SHE RECEIVED ANY RELIEF. DESPITE INCREASED MEDICATION, PATIENT NEVER NOTICED A DIFFERENCE. PT NOTED SHE TRIED MORPHINE & DILAUDID IN THE PUMP AND THOSE DID NOT WORK. PT INDICATED THAT DEMORAL WORKED IN A DRIP, BUT THAT THE HCP WILL NOT PUT IT IN THE PUMP. PATIENT STATED A DYE TEST WAS DONE AND THAT DURING THE PROCEDURE, THE PUMP WAS MOVING REALLY SLOW. PATIENT WAS MOVED TO HER SIDE AND IT STARTED WORKING FASTER. PATIENT INDICATED THE CATHETER MAY BE KINKED. PATIENT FELT PAIN IN HER BACK WHERE IT MAY BE KINKED AND HAD EXPERIENCED THIS PAIN FOR APPROX 2 YEARS. PT INDICATED SHE PREVIOUSLY COULD WALK AND NOW WAS UNABLE TO WALK. ALSO, IT WAS REPORTED THAT DURING A PAST REFILL APPOINTMENT, THERE WAS A VOLUME DISCREPANCY. PT STATED A DYE STUDY WAS CONDUCTED POST VOLUME DISCREPANCY. PT WAS TO HAVE A REFILL AND AN APPOINTMENT WITH HCP TO DISCUSS FINDINGS FROM DYE STUDY. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADD'L INFO WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER: MODEL 8709, LOT# J11486R60| IMPLANTED:| EXPLANTED: