BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4172700 · Received October 10, 2014

    Report

    Report Number
    1627487-2014-24268
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 18, 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 1 OF 2. REFERENCE MFR REPORT# : 1627487-2014-24269. IT WAS REPORTED THE PATIENT IS EXPERIENCING BURNING AND PAIN AT THE IPG SITE WITH STIMULATION ON OR OFF. DIAGNOSTIC TESTING INDICATED INVALID IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. IMAGING INDICATED THE LEAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 AND THE LEAD HAD PULLED OUT OF THE HEADER. THE LEAD WAS RECONNECTED TO THE IPG AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643121 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4120906

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other SCS ANCHOR, MODEL: 1192| IMPLANT DATE: