BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIO

    MDR report key: 3960980 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-03494
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 (B)(6) IS NO LONGER RECEIVING STIMULATION. DIAGNOSTICS SHOWED NORMAL IMPEDANCE VALUES FOR CONTACTS 5-8; HOWEVER, THE CONTACTS SHOULD BE INVALID DUE TO THERE BEING NO PLUG IN THE SCS IPG PORT THAT CORRESPONDS TO THOSE CONTACTS. SURGICAL INTERVENTION WILL BE TAKEN REGARDING THE IPG AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429253 BRIO SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 6788 2850511

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS LEAD: MODEL 6147| IMPLANT DATE: