BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3962474 · Received July 14, 2014

    Report

    Report Number
    1627487-2014-00420
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT ((B)(6)) LOST STIMULATION AND WAS UNABLE TO COMMUNICATE WITH HIS IPG USING EITHER THE PROGRAMMER OF CHARGING SYSTEM. EFFORTS TO ESTABLISH COMMUNICATION USING A DIFFERENT PROGRAMMER ALSO PROVED UNSUCCESSFUL. SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT AND REPLACE THE PATIENT'S IPG. EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PATIENT FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410188 EON MINI SCS IPG GZB ST. JUDE MED - NEUROMODULATION 3788 3535764

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other