BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3851387 · Received May 22, 2014

    Report

    Report Number
    1627487-2014-26430
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    January 30, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT FOR NO MAGNET RESPONSE WAS CONFIRMED. THE RETURNED IPG WAS IN GOOD CONDITION AND A LAB PATIENT PROGRAMMER COMMUNICATED AND CONTROLLED THE IPG NORMALLY; HOWEVER, A MAGNET WOULD NOT TURN STIMULATION ON OR OFF. THE IPG DID NOT PASS THE MAGNET TEST ON THE AUTOTESTER. MANUAL TESTING OF THE MAGNET'S INABILITY TO RELIABLY TURN THE IPG ON AND OFF ALSO CONFIRMED THE FAILURE. INTERNAL ANALYSIS REVEALED THE RED SWITCH (SW1) WOULD STICK AND NOT BE RESPONSIVE TO MAGNETIC INFLUENCES. 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 REPORTED HE CAN NO LONGER UTILIZE HIS MAGNET TO TURN STIMULATION ON OR OFF. IT WAS NOTED THE PATIENT PROGRAMMER AND CHARGING SYSTEM WERE STILL ABLE TO COMMUNICATE WITH THE IPG. A ST. JUDE MEDICAL REPRESENTATIVE MET WITH THE PATIENT TO INTERROGATE THE SYSTEM AND THE REPORTED ISSUE WAS CONFIRMED. DURING THE APPOINTMENT, THE PATIENT REPORTED HE BELIEVES THE ISSUE STARTED AFTER HE FELT A STRONG SHOCK WHILE NEAR THE FREEZER SECTION OF A STORE. THE PATIENT HAS NOT EXPERIENCED ANY FURTHER SHOCKING AFTER THAT INCIDENT AND REPORTS THAT STIMULATION IS WORKING AS INTENDED. THE PATIENT REQUESTED TO HAVE HIS IPG REPLACED. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT HAD HIS IPG EXPLANTED AND REPLACED WHICH RESOLVED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306749 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 4173929

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other IMPLANT DATE:| SCS LEAD, MODEL: 3186 (2)