BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2921614 · Received January 10, 2013

    Report

    Report Number
    1627487-2013-03106
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 WAS NO LONGER RECEIVING STIMULATION IN ADDITION TO EXPERIENCING BRUISING AND SWELLING AT HIS SCS IPG POCKET SITE AFTER FALLING. ADDITIONALLY, THE PATIENT WAS UNABLE TO COMMUNICATE WITH HIS SCS IPG. FOLLOW-UP IDENTIFIED THE PATIENT'S SCS IPG WAS REPLACED WHICH RESOLVED THE STIMULATION AND COMMUNICATION ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14892 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2763824

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3214