BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201706 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00946
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    January 25, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. HCP REPORTED PATIENT WAS IN THE ER WITH INCREASED PAIN AND NAUSEA. THEY WERE PLANNING ON REPLACING THE PUMP AS SOON AS POSSIBLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300803 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR