BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110776 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-12642
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 16, 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. THIS MODEL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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. REF MFR REPORT #1627487-2013-12643. IT WAS REPORTED THE PT HAS BEEN EXPERIENCING HEARING AT THE IPG POCKET SITE WHEN CHARGING. A NEW CHARGER WAS SENT TO THE PT. FOLLOW-UP DETERMINED THE NEW CHARGER RESOLVED THE PT'S ISSUE. ON (B)(4) 2012, ST JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204661 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3467880

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION, MODEL 3383| SCS ANCHOR, MODEL 1192| SCS LEAD, MODEL 3186| IMPLANT DATE: