BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3032274 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-03431
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 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
    MO, 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

    THE PATIENT REPORTED SHE IS NO LONGER RECEIVING STIMULATION DUE TO HER SCS IPG NOT TURNING ON AFTER SHE EXPERIENCED A CAR ACCIDENT. THE PATIENT ALSO REPORTED SHE EXPERIENCED SWELLING AROUND HER SCS IPG POCKET SITE AS WELL AS IN HER LOWER BACK AFTER THE ACCIDENT. FOLLOW-UP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131189 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3619781

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3228