BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3221778 · Received July 9, 2013

    Report

    Report Number
    1627487-2013-12915
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE COMPLAINT FOR "INVALID IMPEDANCE" COULD NOT BE CONFIRMED. NO ALLEGED DEVICE FAILURE WAS IDENTIFIED. CONTINUITY AND STRESS TESTING WAS PERFORMED TO ANALYZE THE CHANNELS' RESISTANCE AND TO VERIFY THE INSULATION CHARACTERISTICS BETWEEN CHANNELS. THE LEAD PASSED ALL FUNCTIONAL TESTING. 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 PHYSICIAN PLACED A TRIAL LEAD. THE IMPEDANCES WERE CHECKED AND SEVERAL OF THE CONTACTS GAVE INVALID IMPEDANCES. THE LEAD WAS REMOVED AND A DIFFERENT LEAD WAS IMPLANTED. THE LEAD WAS TESTED AND PATIENT EXPERIENCED EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312514 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL, NEUROMODULATION 3086 4096033

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other