BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2850621 · Received November 16, 2012

    Report

    Report Number
    1627487-2012-06765
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    April 24, 2012
    Report Date
    October 24, 2012
    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
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: 1627487-07262012-002-R: THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY; 1627487-07262012-001-C: THIS IPG SERIAL NUMBER WAS INCLUDED IN 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

    IT WAS REPORTED, THE PATIENT EXPERIENCES SORENESS, TENDERNESS, AND DISCOMFORT AT THE IPG SITE. IT WAS ALSO REPORTED, THE PATIENT EXPERIENCES A BURNING SENSATION AND TINGLING AT THE IPG SITE WHETHER STIMULATION IS ON OR OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3166007

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention IMPLANT:| SCS LEADS, MODEL: 3186 (2)| IMPLANT:| SCS ANCHORS, MODEL: 1194 (2)