BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3142181 · Received May 29, 2013

    Report

    Report Number
    1627487-2013-06354
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 4, 2013
    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

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN 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. REFERENCE MFR. REPORTS: 1627487-2013-06355 AND 1627487-2013-06356. IT WAS REPORTED THE PT IS EXPERIENCING PAIN AT HER IPG SITE WHEN SHE SITS DOWN. SHE ALSO EXPERIENCES HEATING WHILE CHARGING AND HAS TO TAKE BREAKS DURING CHARGING. THE PT ALSO STATED SHE WAS NOT RECEIVING EFFECTIVE STIMULATION THERAPY IN HER FOOT. ADDITIONALLY, SHE IS HAVING BLURRED VISION AND HEADACHES. THE PT HAS TURNED OFF THE STIMULATION AND HAS DECIDED TO HAVE HER SCS SYSTEM REMOVED. SURGICAL INTERVENTION MAY BE PENDING. ON (B)(4) 2012, ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. 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
    235879 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3697907

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention