BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012210 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-06051
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 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 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 STATES, SHE CONTINUES TO HAVE PAIN AROUND THE IPG AND DOWN THE LEG. SHE HAS NOT USED THE IPG IN MONTHS AND HAS DECIDED TO HAVE THE IPG REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104466 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3339681

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3288