BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2980241 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-02274
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    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

    IT WAS REPORTED THE PT FELL OFF A LADDER AND LANDED ON HIS BUTTOCKS AND BACK INTO SNOW. HE STATED APPROXIMATELY 2 HOURS LATER HIS STIMULATION STOPPED WORKING AND HIS IPG WOULD NO LONGER COMMUNICATE WITH THIS EXTERNAL DEVICES. THE SJM REP CONFIRMED THE IPG WOULD NOT COMMUNICATE AND REPLACEMENT EXTERNAL DEVICES WERE UNABLE TO RESOLVE THE ISSUE. FOLLOW-UP IDENTIFIED THE PT COMPLAINED OF TENDERNESS AT HIS IPG SITE AS WELL AS PAIN, TINGLING AND NUMBNESS TO HIS RIGHT LEG. AN X-RAY WAS TAKEN AND SHOWED NO ANOMALIES TO THE PT'S SYSTEM. IT WAS REPORTED THE PT WAS REFERRED TO AN ORTHOPEDIC SURGEON OT DISCUSS POSSIBLE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78745 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3166006

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE| IMPLANT DATE: