BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203144 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01091
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    October 25, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS DIFFICULTY FINDING THE CENTER PORT FOR REFILLS. THE PUMP WAS IMPLANTED ¿QUITE DEEP IN THE PELVIS¿ AND THE PUMP COULD HARDLY BE FELT. THIS WAS THE REASON THE REFILL PORT WAS DIFFICULT TO FIND. IT WAS NOTED A REVISION WILL BE DONE. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301461 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention