BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4182793 · Received October 17, 2014

    Report

    Report Number
    3007566237-2014-03024
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 8709, LOT# L73872, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS IN (B)(6) FROM 2003-2005. WHEN THE PATIENT WENT BACK TO THE DOCTOR IN (B)(6), SHE WAS TOLD THAT SHE WAS BEING OVERDOSED; THE PATIENT WAS "GETTING FENTANYL AS MG¿. FOLLOW-UP IS BEING DONE TO COLLECT ADDITIONAL INFORMATION REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661885 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other