BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141058 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-03707
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN 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

    THE PT REPORTED HE IS EXPERIENCING A BURNING/ITCHING SENSATION AT HIS IPG POCKET SITE REGARDLESS OF STIMULATION. THE PT WAS ADVISED TO CONSULT WITH THE PHYSICIAN REGARDING THE ISSUE. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232321 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2815247

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: