BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2843460 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-02670
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 20, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    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 ADVISORIES. 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: 1627487-2012-02671 AND 1627487-2012-02672. IT WAS REPORTED THE PATIENT HAD FELT A BURNING/SHOCKING SENSATION FOR THE PAST FEW DAYS THAT STARTS AT HIS IPG SITE AND TRAVELS UP THE LEADS. THE PATIENT REPORTED A SIMILAR SENSATION IN 2010, AND HIS SYSTEM WAS CONSEQUENTLY REPLACED (REFERENCE MFR REPORTS: 1627487-2010-01913 AND 1627487-2010-01939). HE REPORTED HIS STIMULATION IS EFFECTIVE BUT HE FEELS THIS BURNING SENSATION OVER THE STIMULATION. THE PATIENT DENIED ANY FALLS AND NOTICED THE CHANGE WHILE HE WAS SITTING IN A RECLINER. IT WAS REPORTED THE PHYSICIAN PLANS TO OBTAIN X-RAYS OF THE PATIENT'S SYSTEM. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3101643

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention