BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3061814 · Received April 16, 2013

    Report

    Report Number
    3007566237-2013-01306
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH NARCOTIC WITHDRAWAL SYMPTOMS OF NAUSEA, VOMITING, MYALGIA, AND ARTHRALGIA WHICH BEGAN APPROXIMATELY A WEEK AGO. THE HEALTHCARE PROVIDER (HCP) WANTED THE PUMP CHECKED TO ENSURE IT WAS WORKING PROPERLY. THE DEVICE SYSTEM WAS DELIVERING MORPHINE, BUPIVACAINE, AND CLONIDINE. IT WAS ADDITIONALLY REPORTED THAT THE PUMP WAS INTERROGATED AND THE PUMP LOGS DID NOT SHOW ANY ISSUES. IT WAS LATER REPORTED THAT THE PUMP MANAGING PHYSICIAN WAS CONTACTED. THE PATIENT WAS REPORTED TO HAVE THE FLU. NO ADDITIONAL PUMP TROUBLESHOOTING WAS DONE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS REPORTED TO BE DOING BETTER. I WAS NOTED THAT THE PUMP WAS NOT SUSPECTED AS AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161895 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization