BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 8726640 · Received June 24, 2019

    Report

    Report Number
    1627487-2019-07277
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    March 6, 2019
    Report Date
    June 24, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05414734402651
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DIRECTIONS FOR USE STATES THAT THE IMPLANT MUST BE CHARGED EVERY 30 DAYS TO AVOID BATTERY DEPLETION. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT IS RELATED TO USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS INOPERABLE DUE TO THE PATIENT NOT CHARGING. PROGRAMMING CHANGES WERE ATTEMPTED HOWEVER WAS UNSUCCESSFUL DUE TO THE IPG BEING INOPERABLE. IT IS UNKNOWN WHEN THE PATIENT STOPPED CHARGING OR LAST HAD THERAPY. THE DEVICE WAS EXPLANTED, AND A NEW DEVICE WAS IMPLANTED AS A RESULT TO RESOLVE THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE. PATIENT HAD EFFECTIVE COVERAGE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523242 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3797074 05414734402651

    Patients

    Seq Age Sex Outcome Treatment
    1 Other