BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3092132 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07253
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NEWLY IMPLANTED WITH THE PUMP AND WAS UNABLE TO TOLERATE THE 10MG/ML MORPHINE CONCENTRATION. THE REPORTER STATED THAT THE CONCENTRATION WAS "TOO HIGH FOR HER". THE CONCENTRATION WAS BEING CHANGED TO 1MG/ML AND A SYSTEM CONTENT REMOVAL PROCEDURE WAS TO BE PERFORMED. IT WAS LATER REPORTED THAT THE PATIENT OVERDOSED AT 0.48MG/DAY. THE PATIENT EXPERIENCED RESPIRATORY DEPRESSION. AFTER THE MORPHINE CONCENTRATION WAS CHANGED FROM 10MG/ML TO 1MG/ML THE PATIENT WAS STABLE ON A DAILY DOSE OF 0.048MG/DAY. THE PATIENT WAS "DOING FINE" AT THE TIME OF THE REPORT AND THEY WERE WORKING SAFELY ON TITRATING THE DOSE TO AN EFFECTIVE DOSE. IT WAS ALSO NOTED THAT THE PUMP LOGS WERE CHECKED AT THE TIME OF OVERDOSE AND NO ISSUES WERE FOUND WITH THE DEVICE SYSTEM. IT WAS LATER REPORTED THAT THE PATIENT OVERDOSED THREE TIMES ON THE 10MG/ML CONCENTRATION BEFORE BEING REPLACED WITH THE 1MG/ML CONCENTRATION. THE PATIENT STATED THAT ONE OCCASION OF OVERDOSE WAS "THE DAY THAT THEY WENT IN AND DID THE SAMPLE".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT BECAME UNRESPONSIVE WITH THE INITIAL RATE. THE PATIENT REQUIRED HOSPITALIZ ATION DUE TO THE EVENT. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE REPORTER WAS AWARE OF TWO OVERDOSES. THE FIRST OVERDOSE WAS THE NIGHT OF IMPLANT AT WHICH TIME THE PUMP DELIVERED MORPHINE 10MG/ML AT 4MG/DAY; THE SECOND OVERDOSE WAS THE NEXT DAY AFTER THE RATE WAS REDUCED AT WHICH TIME THE PUMP DELIVERED 0.48MG/DAY. THE PATIENT ALSO EXPERIENCED A SYMPTOM OF DROWSINESS. THE REPORTER STATED THAT IT WAS A BRAND NEW PUMP AND THERE WAS NO REASON TO BELIEVE ANYTHING WAS WRONG WITH THE SYSTEM. THE MORPHINE WAS REPLACED WITH 1MG/ML CONCENTRATION SO THE DAILY DOSE COULD BE REDUCED. PATIENT OUTCOME WAS REPORTED AS ¿FINE¿ AND TO THE REPORTER¿S KNOWLEDGE THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194627 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O