BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3182154 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-04767
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    December 22, 2012
    Report Date
    March 17, 2016
    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
    IL, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL #: 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND 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 3. REF MFR REPORT: 1627487-2013-04768 AND 1627487-2013-04769. IT WAS REPORTED THE PT HAD RECEIVED A BURN WHILE RECHARGING THE IPG WITH THE CHARGING SYSTEM. THE PT REPORTED THE INCIDENT HAD HAPPENED 5 MONTHS BEFORE AND A SCAB FORMED AND MORE RECENTLY THERE WAS A SCAR. THE PT REPORTED THE IPG WAS SHALLOW UNDER THE SKIN. IT WAS ALSO REPORTED THE SYSTEM WOULD TURN ON RANDOMLY AND A SHOCKING SENSATION WOULD OCCUR IN HER LEFT LEG WHICH WOULD CAUSE HER TO DRAW HER LEGS TOWARD HER CHEST. THE PT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION AND HAD DISCONTINUED THE USE OF THE SCS SYSTEM. IT WAS REPORTED THE PHYSICIAN PLANNED TO EXPLANT THE SYSTEM. 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
    270996 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3224688

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other