BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141274 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-06339
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT IS EXPERIENCING PAIN AT HER IPG POCKET SITE AFTER CHARGING. THE ISSUE STARTED ABOUT A MONTH AGO. THE PT STATED, SHE FEELS SORENESS AND PAIN AT HER SCIATIC NERVE AREA WHERE THE IPG IS LOCATED. THE PAIN PERSISTS UNTIL THE NEXT DAY. THE PT IS PENDING A F/U WITH HER PHYSICIAN AND AN SJM REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231717 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3780659

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention IMPLANT:| SCS EXTENSION: MODEL 3341| IMPLANT:| SCS LEAD: MODEL 3166| SCS ANCHOR: MODEL 1194| IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192 (X2)| SCS LEAD: MODEL 3146| IMPLANT: