BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3192092 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02866
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 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
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING #: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS 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 PATIENT HAD NOT CHARGED HER IPG IN OVER A YEAR AND WANTS HER SYSTEM REMOVED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281098 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 2789907

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: