BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3042301 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-02462
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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

    THE PATIENT UNDERWENT A PROCEDURE FOR A TRIAL SCS SYSTEM. IT WAS REPORTED THE PATIENT COULD ONLY OBTAIN STIMULATION POSTOPERATIVE IN THE CLINICIAN'S MODE. WHEN TAKEN OUT OF THIS MODE, THE 'OPEN CIRCUIT' MESSAGE ALLEGEDLY APPEARED ON THE MTS. DIAGNOSTIC TESTING SHOWED INVALID IMPEDANCES ON ALL LEAD CONTACTS. IT WAS REPORTED THE TRIAL WAS CONDUCTED SUCCESSFULLY IN THE CLINICIAN'S MODE. THE TRIAL LEAD WAS REMOVED AT A LATER DATE AND WAS DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138410 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3854261

    Patients

    Seq Age Sex Outcome Treatment
    1