BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3192044 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-01725
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 IS EXPERIENCING PAIN AT HIS IPG SITE. THE PATIENT NO LONGER USES HIS SCS SYSTEM AND DOES NOT REMEMBER THE LAST TIME HE CHARGED IT. THE PATIENT'S ENTIRE SCS SYSTEM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281548 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3194819

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS LEAD, MODEL 3228| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)| SCS EXTENSION, MODEL 3383 (2)