BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3101997 · Received May 6, 2013

    Report

    Report Number
    1627487-2013-12629
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    January 21, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2013-12630. IT WAS REPORTED THE IPG WAS NO LONGER ABLE TO COMMUNICATE WIT THE CHARGING SYSTEM. THE PHYSICIAN SUSPECTED THE IPG HAD FLIPPED AND PERFORMED AN EXPLORATORY SURGERY ON (B)(6) 2013. THE PHYSICIAN FOUND THE LEADS TWISTED AROUND THE IPG AND FLUID IN ONE OF THE LEADS. ON (B)(6) 2013 THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD AND IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197297 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 3371405

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention