BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2932145 · Received January 25, 2013

    Report

    Report Number
    1627487-2013-05141
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 5, 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
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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 2. REF MFR REPORT #: 1627487-2013-05142. IT WAS REPORTED THE PT IS EXPERIENCING PAIN, SWELLING, SORENESS, AND REDNESS AT THE IPG SITE. IT WAS ALSO REPORTED THE PT BELIEVES THE IPG HAS MOVED FROM IT'S ORIGINAL LOCATION, AND HAS DISCONNECTED FROM THE LEAD. THE PT ALSO EXPERIENCED PAIN IN HER LEG WHETHER STIMULATION IS ON OR OFF. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36087 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2794640

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention