BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141582 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-13798
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 3. REFERENCE MFR REPORT: 1627487-2013-13799 AND 1627487-2013-13800. IT WAS REPORTED THE PT COULD NOT COMMUNICATE WITH HIS IPG USING EXTERNAL DEVICES. THE PT STATED HE HAS NOT CHARGED HIS IPG FOR OVER 3 MONTHS BECAUSE HE WASN'T RECEIVING EFFECTIVE STIMULATION. THE PT ALSO STATED THE STIMULATION WOULD CHANGE WHEN HE MOVED HIS NECK, HE WOULD FEEL "A SHOCKING SENSATION" IN HIS NECK OR OVERSTIMULATION IN HIS BACK. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232769 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3071753

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR SCS ANCHOR: MODEL 1192 (2)| IMPLANTED: