BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3182190 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-04766
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 PT WAS EXPERIENCING SHOCKING AT THE IPG SITE WHEN THE STIMULATION WAS IN USE. IT WAS REPORTED THE SENSATION WAS NOT PRESENT WHEN THE STIMULATION WAS TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271508 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3902044

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)