BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202681 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04601
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 15, 2012
    Report Date
    May 15, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. PATIENT REPORTED HE HAD MORPHINE IN THE PUMP AND HCP ADDED MARCAINE, BUT IT WAS TOO MUCH AND IT MADE HIM NAUSEOUS AND THROW UP, POSSIBLY OVERDOSED AND THEN THEY BROUGHT THAT DOSAGE DOWN AND ADDED BACLOFEN AS WELL. PATIENT REPORTED HIGH PAIN. HCP LATER REPORTED THE PATIENT HAD NAUSEA FOR SEVERAL MONTHS AND WAS REFERRED TO A GASTROENTEROLOGIST AND PCP FOR NAUSEA. HCP DID NOT KNOW IF THE EVENT WAS DUE TO PUMP OR DRUG EFFECT. OUTCOME WAS REPORTED AS NO INJURY. THE SYSTEM USED TO DELIVER MORPHINE, BACLOFEN AND BUPIVACAINE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300814 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Other