BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4853489 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-11844
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    June 1, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8781, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN "UP AND DOWN" FOR THE PAST YEAR, SOMETIMES FEELING LIKE THE PUMP WAS NOT WORKING AND SOMETIMES FEELING LIKE SHE WAS GETTING TOO MUCH. THE PATIENT¿S SYMPTOMS INCLUDED FEELING NAUSEOUS, JITTERY, LIGHTHEADED, AND SICK. THE PATIENT WOULD FEEL FINE THEN BE IN BED FOR 2 DAYS FEELING ACHY LIKE SHE WAS GETTING SICK THEN BE FINE AGAIN. THE PATIENT HAD HAD TO TAKE EXTRA MEDS AT TIMES. THE PATIENT WAS UNSURE IF IT WAS RELATED TO THE PUMP. THE PUMP STARTED CRITICALLY ALARMING ON (B)(6) 2015. TELEMETRY HAD NOT YET BEEN DONE. THEY HAD CONTACTED THE DOCTOR¿S OFFICE, BUT HAD NOT HEARD BACK AS OF (B)(6) 2015. THE PATIENT DID HAVE OTHER MEDS (NORCO) TO TAKE IF NEEDED. THE DEVICE SYSTEM WAS DELIVERING BUPIVACAINE AND MORPHINE. THE INTERVENTIONS AND OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398550 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Other