BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2980037 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-01215
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 1, 2012
    Report Date
    January 30, 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
    GA, 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 PATIENT WAS EXPERIENCING AN INCREASED CHARGE BURDEN AND IS NO LONGER RECEIVING EFFECTIVE STIMULATION. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT EXPERIENCED A SUDDEN LOSS OF STIMULATION AND WAS UNABLE TO COMMUNICATE WITH OR CHARGE HER IPG. THE PATIENT'S IPG WAS REPLACED WITH A NEW ONE AND IS NOW RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77663 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 55142

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCS LEAD: MODEL 3208| IMPLANT DATE: