BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3894064 · Received June 25, 2014

    Report

    Report Number
    3007566237-2014-01768
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2008-(B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD (B)(6) IN ONE OF THE PUMP SITES AND HAD TO MOVE THE PUMP. THE EVENT OCCURRED 6 YEARS AGO. THE DRUG IN THE PUMP AT THE TIME OF EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371713 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention