BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110663 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-08060
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORY AND FIELD CORRECTION. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-08061. IT WAS REPORTED THE PT EXPERIENCED HEATING OF POCKET SITE WHILE RECHARGING AND ALSO HAD DARK MARKS NEAR THE IPG (IMPLANTABLE PULSE GENERATOR) SITE. IT WAS REPORTED HE WAS UNABLE TO RECHARGE THE DEVICE AS THE CHARGER STOPPED WORKING. REPLACEMENT CHARGER WAS NOT ABLE TO COMMUNICATE WITH THE IPG. F/U INFO SUGGESTED THE PHYSICIAN WILL BE CONSULTED ABOUT THE POTENTIAL IPG REPLACEMENT AT A FUTURE DATE. 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
    205579 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3290709

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCS LEAD: MODEL 3186| IMPLANT DATE: