BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTAD STANDARD LEAD 1X8

    MDR report key: 1934187 · Received December 8, 2010

    Report

    Report Number
    3007566237-2010-10311
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO REPORTING A PROBLEM WITH THE LEAD DURING IMPLANT. THE PHYSICIAN WAS UNABLE TO INTRODUCE ANY OF THE TWO GREEN STYLETS INTO THE LEAD. THE WHITE STYLETS WOULD FIT FINE, BUT NONE OF THE GREEN. THE GREEN STYLETS SEEMED TO BE THICKER THAN THE INNER LUMEN OF THE LEAD. FOR PROPER POSITIONING IN THIS PT, A RIGID STYLET WAS NECESSARY. THE PHYSICIAN OPENED A NEW OCTOPOLAR LEAD WHOSE GREEN STYLET FIT PROPERLY INTO THE LUMEN. THE IMPLANT WAS COMPLETED SUCCESSFULLY AND THE PT IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTAD STANDARD LEAD 1X8 LGW MEDTRONIC NEUROMODULATION 3877 0204052255

    Patients

    Seq Age Sex Outcome Treatment
    1