BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2771964 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-06481
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    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

    AN IMPEDANCE CHECK WAS PERFORMED AFTER THE IPG WAS IMPLANTED AND REVEALED INVALID IMPEDANCE. X-RAYS WERE TAKEN AND THE LEADS WERE FOUND TO BE DISCONNECTED FROM THE IPG HEADER. THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM AND THE LEADS WERE RECONNECTED TO THE IPG HEADER. RECONNECTING THE LEADS RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3597339

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT:| SCS LEADS, MODEL: 3186 (2)