BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3170946 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10407
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    February 14, 2013
    Report Date
    November 30, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED EVAL CODE-CONCLUSIONS WERE UPDATED TO (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A REPRESENTATIVE REPORTED THAT, AT THE PATIENT¿S LAST REFILL ON (B)(6) 2013, THE CONCENTRATION WAS CHANGED, ¿BUT THAT CONCENTRATION WOULD NOT CHANGE IN THE ACTUAL PROGRAMMER¿. THE REPRESENTATIVE CONFIRMED THAT THEY DID NOT CHANGE THE PROGRAMMED CONCENTRATION, AND A BRIDGE BOLUS WAS NOT PERFORMED. THE MEDICATION USED WITHIN THE SYSTEM WAS CHANGED FROM 10 MG/ML TO 15 MG/ML. FURTHER DISCUSSION REVEALED THE PATIENT WAS RECEIVING 2.64 MG/DAY INSTEAD OF 1.76 MG/DAY. THE PATIENT WAS NOTED TO BE ¿TOTALLY ASYMPTOMATIC AND DOING WELL¿. THE PATIENT WAS NOTED TO HAVE BEEN ON FLEX DOSING, AND THE REPRESENTATIVE INDICATED THEY WOULD SPEAK TO THE PHYSICIAN TO SEE HOW THE EXTRA 0.88 MG/ML WOULD BE DISTRIBUTED IN THE FLEX DOSING. THE PATIENT WAS HAVING A REFILL ON THE DAY OF THE REPORT. THE MEDICATION USED WITHIN THE SYSTEM WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271800 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR