BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4060854 · Received August 6, 2014

    Report

    Report Number
    1627487-2014-20093
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 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 INFO 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 # 1627487-2014-20092. THE PATIENT HAS TWO SCS IPGS. IT IS UNKNOWN WHICH ONE IS RELATED TO THE ISSUE, THEREFORE, BOTH ARE BEING REPORTED. IT WAS REPORTED THE PATIENT IS EXPERIENCING DISCOMFORT AND BURNING PAIN AT THE SCS IPG POCKET SITE THAT IS LOCATED AT HER BELT LINE WHICH BECOMES WORSE WITH STIMULATION. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461697 EON SCS IPG GZB ST. JUDE MEDICAL, NEUROMODULATION 3716 96422

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other SCS LEAD, MODEL 3186| IMPLANT DATE:| SCS LEAD, MODEL 3186| IMPLANT DATE: