BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3950164 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-00393
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P10032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 (AUSTRALIA EXPERIENCES SEVERE DISCOMFORT AT THE IPG SITE WHEN STIMULATION IS IN USE. VISUAL INSPECTION OF THE AREA IN QUESTION REVEALED SKIN DISCOLORATION. THE PT HAS REPORTEDLY LOST WEIGHT, AND THE IPG IS PROTRUDING AS A RESULT. DESPITE THESE ISSUES, THE PT IS SAID TO BE RECEIVING EFFECTIVE STIMULATION. A DECISION REGARDING THE NEXT COURSE OF ACTION IN THIS MATTER HAS NOT BEEN REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376672 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 2839895

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other IMPLANT DATE: 01/01/2010| SCS LEAD, MODEL: 3183