BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201445 · Received July 2, 2013

    Report

    Report Number
    3007566237-2012-03093
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, 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 HAVING A MAGNETIC RESONANCE IMAGE (MRI) TO LOOK FOR AN INFLAMMATORY MASS. THE INFLAMMATORY MASS HAD NOT BEEN CONFIRMED. THE PATIENT WAS BEING TESTED BECAUSE THEY EXPERIENCED A DECREASE IN THERAPEUTIC EFFECT. 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
    303415 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention