BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3140978 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-05729
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2013-05730. IT WAS REPORTED THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IPG SITE AD INADEQUATE COVERAGE. AS A RESULT, THE IPG WAS EXPLANTED AND REPLACED (WITH DIFFERENT MODEL). THE REPLACEMENT IPG WAS IMPLANTED IN A NEW LOCATION. AN ADDITIONAL LEAD WAS ALSO IMPLANTED TO OBTAIN ADEQUATE COVERAGE. SURGICAL INTERVENTION RESOLVED THE PATIENT'S ISSUES. THE EXPLANTED PRODUCT WAS DISPOSED OF BY THE SURGICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231744 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3752928

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention