BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 8621390 · Received May 17, 2019

    Report

    Report Number
    1627487-2019-05743
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 17, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE THERAPY WITH THEIR SCS SYSTEM. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THEIR IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414157 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788ANS 3535805

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other