BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2992487 · Received March 4, 2013

    Report

    Report Number
    1627487-2013-03314
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    September 6, 2012
    Report Date
    February 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R 1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. SJM HAS LIMITED INFO 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 REPORTS: 1627487-2013-03315. THE PT REPORTED SHE EXPERIENCED HEATING AND BEING BURNED AT HER SCS IPG POCKET SITE WHILE CHARGING HER SCS SYS. THE PT ALSO REPORTED SHE WENT TO THE ER AS A RESULT OF THE BURN. SUBSEQUENTLY, THE PT REDUCED HER CHARGING FREQUENCY. ALSO, A REPLACEMENT CHARGING SYS (LOW ENERGY) WAS SENT TO THE PT. F/U IDENTIFIED THE ISSUE HAS NOT BEEN RESOLVED; IN ADDITION, THE PT IS NO LONGER RECEIVING EFFECTIVE STIMULATION AFTER ENCOUNTERING A METAL DETECTOR. FURTHERMORE, THE PT EXPERIENCED A SHOCK DURING THE ENCOUNTER AND REPORTS HER SCS SYS MALFUNCTIONING FROM THAT POINT. ON (B)(4) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIV, 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
    91584 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3108343

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3186 (2)