BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 8685350 · Received June 10, 2019

    Report

    Report Number
    1627487-2019-06793
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 10, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S SCS IPG WAS REPLACED. REPORTEDLY, THE PATIENT HAD NOT CHARGED THE IPG IN SEVERAL MONTHS AND THE SYSTEM WAS NON-FUNCTIONAL. STIMULATION THERAPY WAS RESTORED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478375 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3359052

    Patients

    Seq Age Sex Outcome Treatment
    1 Other