BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3961318 · Received July 18, 2014

    Report

    Report Number
    1627487-2014-20057
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ST JUDE MED - NEUROMODULATION SYSTEMS
    Product Code
    GZB
    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

    DEVICE 2 OF 2. REF MFR REPORT# 1627487-2014-20056. IT WAS REPORTED THE PATIENT IS NO LONGER RECEIVING STIMULATION AS THE SCS LEAD HAS MIGRATED OUT OF THE EPIDURAL SPACE (X-RAYS CONFIRMED). ALSO, DIAGNOSTICS CONFIRMED LOW IMPEDANCE VALUES. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421077 EONC SCS IPG GZB ST JUDE MED - NEUROMODULATION SYSTEMS 3688 4525615

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other SCS IPG, MODEL 3688| IMPLANT: