BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3134044 · Received May 23, 2013

    Report

    Report Number
    1627487-2013-08140
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    September 24, 2010
    Report Date
    May 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES 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 3. REFERENCE MFR REPORT: 1627487-2013-08041, 08042. IT WAS REPORTED THE PT'S IPG (IMPLANTABLE PULSE GENERATOR) SITE BECAME HOT WHEN USING THE CHARGER. A REPLACEMENT CHARGER WAS SET TO THE PT TO ADDRESS THE ISSUE. IT WAS ALSO REPORTED, SINCE THE IMPLANT DATE THE PT HAD UNINTENDED STIMULATION AND SHOCKING IN THE IPG AREA WHEN THE STIMULATION WAS ON. ON 08/01/2012 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
    229171 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3162158

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention