BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2973614 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-13313
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    November 30, 2011
    Report Date
    January 26, 2013
    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

    ADD'L # 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFO 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

    IT WAS REPORTED THE PT WAS EXPERIENCING PAIN AT HIS IPG SITE. THE PT STATED THE PAIN STARTED APPROX 8 MONTHS AFTER THE SCS SYSTEM WAS IMPLANTED. THE PT WAS PROVIDED WITH NEW PROGRAMS TO TRY AND SEE IF THEY WOULD PROVIDE BETTER STIMULATION COVERAGE FOR HIS DESIRED PAIN AREAS. SURGICAL INTERVENTION MAY BE TAKEN TO MOVE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72630 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3300065

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3219