BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3162395 · Received June 6, 2013

    Report

    Report Number
    1627487-2013-01661
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 IS EXPERIENCING DIFFICULTY COMMUNICATING WITH HER IPG USING HER CHARGER DUE TO THE IPG BEING TILTED IN THE POCKET. THE PATIENT IS CONSIDERING REVISION SURGERY TO RELOCATE HER IPG POCKET SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251379 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3456517

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SCS LEAD, MODEL 3214| IMPLANT DATE: