BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE TRIAL LEAD, 60 CM

    MDR report key: 2113805 · Received May 17, 2011

    Report

    Report Number
    1627487-2011-00685
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    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 LEAD WAS INTENDED FOR TRIAL PATIENT IMPLANT. HOWEVER, DURING INTRAOPERATIVE TESTING, HIGH IMPEDANCE MEASUREMENTS WERE OBSERVED ON ALL LEAD CONTACTS. EFFORTS TO RESOLVE THIS MATTER WITH THE USE OF MULTIPLE TRIAL CABLES AND TRIAL STIMULATORS AND REPOSITIONING OF THE LEAD PROVED UNSUCCESSFUL. THE PHYSICIAN USED ANOTHER LEAD TO SUCCESSFULLY COMPLETE THE CASE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE TRIAL LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3244555

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention