BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 2982067 · Received February 8, 2013

    Report

    Report Number
    1627487-2013-00081
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    DURING A TRIAL IMPLANT PROCEDURE IN (B)(6), IT WAS REPORTED INVALID IMPEDANCE MEASUREMENTS WERE OBSERVED WITH THE LEAD. VARIOUS TROUBLESHOOTING METHODS WERE UNDERTAKEN INTRAOPERATIVELY TO RESOLVE THE ISSUE BUT TO NO AVAIL. THE PROCEDURE WAS COMPLETED WITH THE USE OF A NEW LEAD ND A NEW TRIAL CABLE. NO FURTHER IMPEDANCE ISSUES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55249 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3792170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention