BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 4860457 · Received June 22, 2015

    Report

    Report Number
    1627487-2015-10209
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 5, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN T THE IPG POCKET SITE. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE PHYSICIAN REVISED THE POCKET SITE FOR COMFORT. THE PHYSICIAN DECIDED TO REPLACE THE IPG WITH A PROTÉGÉ MRI (ELECTIVELY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403383 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3586528

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other MODEL 3186 (2), SCS LEAD| MODEL 1194 (2), SCS ANCHOR