BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4193438 · Received October 20, 2014

    Report

    Report Number
    1627487-2014-02731
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 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
    NL
    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 (NETHERLANDS) COMPLAINED THE SCS STIMULATION TURNS OFF WHEN ATTEMPTING TO INCREASE. THE PATIENT DOES NOT HAVE EFFECTIVE STIMULATION FOR THE RIGHT LEG. REPROGRAMMING WAS ATTEMPTED, BUT WAS UNSUCCESSFUL IN REGAINING EFFECTIVE STIMULATION FOR THE PATIENT. A SYSTEM DIAGNOSTICS INDICATED HIGH IMPEDANCES ON CONTACT 16 FOR THE PATIENT'S RIGHT LEAD. THE NEXT COURSE OF ACTION TO ADDRESS THE ISSUE IS UNDETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666790 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3186 3518091

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SCS IPG: MODEL 3716| SCS LEAD: MODEL 3186| IMPLANT:| IMPLANT: