BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3173725 · Received June 17, 2013

    Report

    Report Number
    6000030-2013-00162
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 23, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L69629, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN TURNED UP THE MEDICATION SO HIGH THAT THE PATIENT OVERDOSED. AT THE TIME OF REPORT, THE DEVICE SYSTEM WAS USED TO DELIVER CLONIDINE, BACLOFEN, AND DILAUDID, THOUGH IT WAS UNCLEAR IF THAT MEDICATION WAS STILL IN USE AT THE TIME OF THE EVENT BACK IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274047 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other