BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3132855 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08243
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: PRODUCT ID 8840, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AT THE PATIENT¿S LAST REFILL ON (B)(6) 2013, THE CONCENTRATIONS OF MEDICATIONS WERE CHANGED FROM MORPHINE 20 MG/ML AND BUPIVACAINE 12 (UNITS UNKNOWN)/ML TO MORPHINE 40 MG/ML AND BUPIVACAINE 24. THE PROGRAMMER ¿WAS NOT ADJUSTED TO REFLECT THAT¿. THE PATIENT WAS KEPT ON THE SAME DOSE AND ¿THEY KEPT EVERYTHING THE SAME¿. THE PATIENT COMPLAINED OF INCREASED PAIN. IT WAS THOUGHT THAT THE PATIENT ¿ESSENTIALLY WAS GETTING DOUBLE WHAT THEY INTENDED FOR HER TO GET¿. IT WAS LATER REPORTED THAT THE PATIENT¿S CANCER HAD SPREAD RAPIDLY AND HER PAIN WAS INCREASING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234272 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention