BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3032224 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-05447
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 HAD NOT RECHARGED THE IPG AS RECOMMENDED. AS A RESULT, THE IPG BECAME NON-FUNCTIONAL AND THE CHARGER/PROGRAMMER COULD NO LONGER COMMUNICATE WITH IT. THE PATIENT'S IPG WAS EXPLANTED AND REPLACED. THE REPLACEMENT IPG RESOLVED THE PATIENT'S ISSUE. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131165 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3646151

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention SCS LEADS: MODEL 3186(X2)| IMPLANT DATE: