BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3850640 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-02376
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    June 20, 2013
    Report Date
    May 7, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL 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

    IT WAS REPORTED THE PT WAS EXPERIENCING WARMTH AT HIS IPG SITE WHEN STIMULATION WAS ON. THE PT WAS SEEN BY HIS PHYSICIAN AND IT WAS DETERMINED THAT A REVISION WOULD BE NECESSARY TO ADDRESS THIS ISSUE AND ADD'L POCKET PAIN THE PT WAS EXPERIENCING DUE TO LOSING WEIGHT. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317321 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2872732

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other SCS EXTENSION: MODEL 3386 (X2)| IMPLANT DATE: