BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3003827 · Received March 14, 2013

    Report

    Report Number
    3007566237-2013-00775
    Event Type
    Injury
    Date Received
    March 14, 2013
    Report Date
    February 13, 2013
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER: PRODUCT ID 8578, LOT# N084327, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS NOT WORKING AND WAS SCHEDULED TO BE REPLACED AND THEY WILL FILL IT WITH DILAUDID. IT WAS UNKNOWN THE EXACT REASON THE PUMP WAS BEING REPLACED NOR WHAT THE MEDICATION WAS IN THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107320 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention