BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012114 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-06059
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORIES. SJM HAS LIMITED INFO 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 162787-2013-06060. IT WAS REPORTED THE PT'S IPG CHARGER GETS HOT AND BURNS HER SKIN. A NEW LOW ENERGY CHARGER WAS SENT TO THE PT TO ADDRESS THIS ISSUE. F/U INDICATES THE NEW CHARGER IS FUNCTIONING BURNS HER SKIN. A NEW LOW ENERGY CHARGER WAS SENT TO THE PT TO ADDRESS THIS ISSUE. F/U INDICATES THE NEW CHARGER IS FUNCTIONING PROPERLY AND THE PT IS NO LONGER HAVING ANY HEATING ISSUES WHILE CHARGING. ON (B)(4) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106446 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 277693

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3214