BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3110687 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-01503
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 IS UNABLE TO COMMUNICATE WITH OR CHARGE HER IPG. SHE HAS NOT USED OR CHARGED HER SCS SYSTEM FOR SEVERAL MONTHS. AN SJM REP MET WITH THE PT AND CONFIRMED THE ISSUE. FOLLOW-UP INFORMATION IDENTIFIED THE PT'S ENTIRE SCS SYSTEM WAS REPLACED WITH A NEW ONE. THE PT IS NOW RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205888 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 50408

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3186