BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEON MINI

    MDR report key: 3182180 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-01685
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2012
    Report Date
    May 20, 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 INA FIELD ADVISORY. 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 IS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES AND HAS LOST STIMULATION. AN SJM REP MET WITH THE PATIENT AND CONFIRMED THE ISSUE. FOLLOW UP INFO IDENTIFIED THE PATIENT'S IPG WAS REPLACED WITH A NEW ONE AND THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272299 SEON MINI SCS IPG LGW ST. JUDE MEDICAL -NEUROMODULATION 3788 3240783

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE: