BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 4760218 · Received May 8, 2015

    Report

    Report Number
    1627487-2015-05236
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 16, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE PATIENT HAS AN SCS SYSTEM FOR OFF-LABEL USE. IT WAS REPORTED THE PATIENT PLANS TO UNDERGO SURGICAL INTERVENTION DUE TO EXPERIENCING DISCOMFORT AT THE IPG SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303955 EON RECHARGEABLE IPG, 16-CHANNEL SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 3740869

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other MODEL: 3346(X2), SCS EXTENSIONS| MODEL: 3169(X2), SCS LEADS| MODEL: 3166(X2), SCS LEADS