BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4092020 · Received August 27, 2014

    Report

    Report Number
    1627487-2014-01558
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    November 5, 2014
    Report Date
    January 15, 2015
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    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

    IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN AT THE IPG SITE REGARDLESS OF STIMULATION BEING ON OR OFF. REPROGRAMMING WAS DECLINED AS THE PATIENT HAS REQUESTED TO HAVE THE SYSTEM EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518630 EON MINI SCS IPG GZB ST. JUDE MEDICAL, NEUROMODULATION 3788 2788115

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)