BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2903205 · Received January 2, 2013

    Report

    Report Number
    1627487-2013-00005
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 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
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 PATIENT ((B)(6)) IS WITHOUT STIMULATION AND UNABLE TO ESTABLISH COMMUNICATION WITH THE IPG VIA THE PROGRAMMER. THIS ISSUE WAS NOTICED DURING THE PATIENT'S RECENT ATTEMPT TO INITIATE THERAPY FOLLOWING A BRIEF SCS SYSTEM HIATUS. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012 EON MINI SCS IPG LGW ST. JUDE MEDICAL -NEUROMODULATION 3788 2897073

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention