BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3181822 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10692
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP MEDICATION DOSE WAS INITIALLY ¿TOO HIGH¿ AND CAUSED AN OVERDOSE. THE PATIENT STATED, ¿MY BRAIN JUST CAN¿T HANDLE MUCH IN THE WAY OF NARCOTICS¿, AND "IT TURNED OUT TO BE TOO MUCH FOR ME AND I JUST COULDN'T HANDLE IT." THE DOSE WAS SUBSEQUENTLY DECREASED AND THE PATIENT WAS THEN ¿IN A LOT OF PAIN¿. THE PUMP ORIGINALLY HAD MORPHINE BUT WAS CHANGED TO DILAUDID ¿ABOUT A MONTH¿ PRIOR TO THIS REPORT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282247 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Other