BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3123485 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-04613
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND A FIELD CORRECTION. 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

    DEVICE 1 OF 2. REF MFR REPORT: 1627487-2013-04614. IT WAS REPORTED THE PT HAD EXPERIENCED HEATING AT THE IPG SITE AND IT HAD CAUSED BLISTERS ON THE SKIN. THE PT STATED THE HEATING SEEMED TO RADIATE THROUGHOUT HIS BACK. THE PT STOPPED USING THE SYSTEM ABOUT 2 MONTHS AGO AND IT WAS REPORTED HE HAD BLACK MARKS ON HIS BACK. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. AN ATTEMPT TO CONTACT THE PT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219268 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3322566

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3228