BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3231553 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-03966
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 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
    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

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-03965. THE PT'S RECORDS INDICATE THE PT UNDERWENT AN SCS IPG REPLACEMENT PROCEDURE ON (B)(6) 2010. AT THIS TIME, IT IS UNK WHETHER THE ORIGINAL OR CURRENT IPG IS RELATED TO THIS ISSUE; THEREFORE, BOTH ARE BEING REPORTED. IT WAS REPORTED THE PT EXPERIENCED HEAT AT THE SCS IPG POCKET SITE AT ALL TIMES WHICH CAUSED PAIN AND DARKENED SCAR TISSUE AT THE POCKET SITE. IT WAS ALSO REPORTED THAT PT EXPERIENCED CHARGING ISSUES WITH HER SCS IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322230 EON SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3716 2898575

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other SCS LEAD: MODEL 3214| IMPLANT DATE: