BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3931702 · Received June 23, 2014

    Report

    Report Number
    1627487-2014-00380
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 28, 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
    AS
    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 # 1627487-2014-00381. IT WAS REPORTED THE PATIENT (B)(6) IS EXPERIENCING A BURNING SENSATION IN HER TONGUE WHEN STIMULATION IS IN USE. A NERVE BLOCK WAS PERFORMED IN AN EFFORT TO RESOLVE THIS MATTER; HOWEVER, THE RELIEF WAS ONLY TEMPORARY. THE PHYSICIAN SUSPECTS THE ISSUE STEMS FROM THE PATIENT'S IPG. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367059 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3189 3879430

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK