BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2890794 · Received December 21, 2012

    Report

    Report Number
    1627487-2012-15076
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 28, 2012
    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
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING #: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER IS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFO 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

    IT WAS REPORTED THE PT WAS NO LONGER RECEIVING STIMULATION AND WAS UNABLE TO COMMUNICATE WITH HIS IPG. REPLACING THE CHARGER DID NOT RESOLVE THE ISSUE. THE SCS REP MET WITH THE PT AND CONFIRMED THE ISSUE. A SECOND REPLACEMENT CHARGER WAS SENT TO ADDRESS THIS ISSUE. THE PT ALSO INDICATED HE HAS LOST ABOUT 100 POUNDS. X-RAYS INDICATED THE SCS IPG APPEARS TO HAVE FLIPPED. THE PT WAS TO MEET WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2878010

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention