BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 8405235 · Received March 8, 2019

    Report

    Report Number
    1627487-2019-03182
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    May 24, 2018
    Report Date
    March 8, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING SENSATION WHILE WALKING THROUGH THE KITCHEN. THE PATIENT UNDERWENT A BTE TRIAL WHICH RESOLVED THE ISSUE. HOWEVER, THE PATIENT SUGGESTED AN UPGRADED IPG. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198410 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3615811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other