BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110669 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-01511
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 18, 2013
    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
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFORMATION 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 IS NOT RECEIVING STIMULATION AND IS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. THE PT HAS NOT CHARGED HIS IPG IN OVER A MONTH. A REPLACEMENT CHARGER WAS UNABLE TO RESOLVE THE ISSUE. THE PT DECLINED MEETING WITH AN SJM REP AND STATED, HE DOES NOT WANT TO HAVE THE SCS SYSTEM REMOVED. THE PT STATED HE IS MANAGING HIS PAIN WITH MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205581 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2788117

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3186