BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2902979 · Received December 26, 2012

    Report

    Report Number
    1627487-2012-16010
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    October 2, 2012
    Report Date
    July 1, 2015
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. SJM HAS LIMITED INFO 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 #1627487-2012-16011. IT WAS REPORTED THE PT EXPERIENCES HEATING AND STATIC ELECTRICITY WHILE RECHARGING THE IPG. A NEW CHARGER WAS SENT TO THE PT. NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME. 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
    1 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3721996

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention IMPLANT:| SCS LEAD: MODEL 3228| IMPLANT:| SCS LEAD: MODEL 3228