BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3960327 · Received June 23, 2014

    Report

    Report Number
    1627487-2014-00379
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S (AUSTRALIA) NEWLY IMPLANTED LEAD IS NOT PROVIDING COVERAGE TO THE PT'S TEMPORAL REGIONAL (OFF-LABEL). F/U ON THIS MATTER FOUND THAT THE LEAD HAS STOPPED FUNCTIONING. ONLY A SLIGHT TINGLING CAN BE FELT IN THE PT'S NECK WHEN STIMULATION AMPLITUDE SETTINGS ARE HIGH. ADD'L PROGRAMMING WILL BE UNDERTAKEN IN AN ATTEMPT TO ADDRESS THIS ISSUE. THERE ARE NO PLANS FOR INVASIVE INTERVENTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366089 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3189 4182871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SCS LEAD: MODEL 3189| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788