BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2903034 · Received January 3, 2013

    Report

    Report Number
    1627487-2013-12031
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ST. JUDE MEDICLA - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL NUMBERS: 1627487-07262012-002-R, 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND IN A 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 #1627487-2013-12032. IT WAS REPORTED THE PT EXPERIENCED POCKET HEATING AND A 'STABBING PAIN' WHILE CHARGING. THE PT ALSO EXPERIENCES SOME OVERSTIMULATION. REPORTEDLY THE PT'S SHOULDER BLADE IS SWOLLEN AND PAINFUL, DUE TO THE LOCATION OF THE IPG. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARING 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
    2088 EON MINI SCS IPG LGW ST. JUDE MEDICLA - NEUROMODULATION 3788 2802182

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention SCS LEAD: MODEL 2342| IMPLANT DATE:| SCS ANCHOR: MODEL 1194| IMPLANT DATE: