BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2861079 · Received December 4, 2012

    Report

    Report Number
    1627487-2012-03797
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODUALTION
    Product Code
    LGW
    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

    SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALTHOUGH THE PT IS RECEIVING STIMULATION, HER CHARGING SYSTEM IS UNABLE TO LOCATE HER SCS IPG. A SJM REPRESENTATIVE CONFIRMED THE INABILITY OF THE SCS IPG TO BE LOCATED BY USING A DEMO CHARGING SYSTEM. IT HAS BEEN DETERMINED THAT THE SCS IPG IS NOW AT AN ANGLE. ADDITIONALLY, THE ISSUE COULD BE DUE TO SWELLING. A SJM REPRESENTATIVE IS TO ATTEMPT ADDITIONAL TROUBLESHOOTING. FOLLOW-UP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODUALTION 3788 3818684

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3219