BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3031968 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-15418
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-12192011-003-R, 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND A FIELD CORRECTION. 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: 1627487-2013-15419. IT WAS REPORTED THE PT IS EXPERIENCING HEATING AT HIS IPG SITE WHILE CHARGING. THE PT INDICATES THE HEATING CAUSED DISCOMFORT TO THE POINT THAT HE STOPPED CHARGING. THE PT WAS SENT A LE CHARGING SYSTEM AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128174 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2791009

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186| IMPLANT DATE:| SCS EXTENSION: MODEL 3386 (3)