BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 2821131 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-02559
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 1, 2012
    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 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 EXPERIENCED PAIN AT HIS IPG SITE. THE PT STATED HE HAD EFFECTIVE STIMULATION COVERAGE BUT HE ELECTED TO HAVE HIS SYSTEM REMOVED DUE TO THE ISSUE. THE PHYSICIAN REMOVED THE SCS SYSTEM AND REPORTED THERE WERE NO SIGNS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3269350

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186| SCS ANCHOR: MODEL 1192| IMPLANT DATE: