BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2894844 · Received December 20, 2012

    Report

    Report Number
    1627487-2012-02858
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ST. JUDE MEDICAL - 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 REPORTING NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 3. REFERENCE MFR REPORTS: 1627487-2012-02859, 02860. IT WAS REPORTED THE PT EXPERIENCED COMMUNICATION ISSUES WITH HIS IPG. HE STATED HE FELL DOWN THE STAIRS ABOUT 4 WEEKS AGO AND A WEEK LATER HE FELT A "BITING" SENSATION AROUND THE IPG SITE WITH STIMULATION ON. THE PT ALSO REPORTED HE DID NOT HAVE ADEQUATE STIMULATION COVERAGE ANY LONGER IN HIS UPPER BACK. REPROGRAMMING WAS UNABLE TO RESOLVE THE UNCOMFORTABLE SENSATION NOR THE INADEQUATE COVERAGE. THE PT STATED THE PAIN IS UNBEARABLE AND HE WANTS HIS SYSTEM REMOVED. DIAGNOSTIC TESTING REVEALED NO ANOMALIES. IT WAS REPORTED X-RAYS HAVE BEEN ORDERED AND A REVISION SURGERY IS BEING CONSIDERED. 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 3062685

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention