BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3900125 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-01342
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ST JUDE MEDICAL -NEUROMODULATION
    Product Code
    GZB
    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 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

    IT WAS REPORTED THAT THE PATIENT'S EXPERIENCING AN INTERMITTENT BURNING SENSATION AT THE IPG SITE REGARDLESS OF STIMULATION USE. THE ISSUE IS NOT RELATED TO RECHARGING. THE DEVICE WAS TURNED OFF DUE TO THE SYMPTOMS. SUBSEQUENTLY, THE PATIENT PRESENTED TO THE ER. THERE WERE NO VISIBLE SIGNS OF SWELLING OR REDNESS AT THE IPG SITE. FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A FUTURE DATE. THE PATIENT WILL TRY LIDOCAINE PAIN PATCHES UNTIL SUCH A TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315175 EON SCS IPG GZB ST JUDE MEDICAL -NEUROMODULATION 3716 3416838

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention SCS LEAD: MODEL 3186 (2),| SCS ANCHOR: MODEL 1192 (2),| IMPLANT DATE:| IMPLANT DATE: