BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3050813 · Received April 10, 2013

    Report

    Report Number
    3007566237-2013-01199
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REMOVED 'ABOUT FIVE YEARS AGO' BECAUSE HE 'DEVELOPED SPINAL MENINGITIS DUE TO INFECTION IN THE PUMP.' IT WAS LATER REPORTED THAT THE HEALTHCARE PROVIDER HAD NOT SEEN THE PATIENT SINCE 2007, THEY HAD HEARD ABOUT THE INFECTION HOWEVER THE PATIENT WAS TREATED AT A DIFFERENT FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153416 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R