BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 6620451 · Received June 7, 2017

    Report

    Report Number
    1644487-2017-03937
    Event Type
    Malfunction
    Date Received
    June 7, 2017
    Date of Event
    May 30, 2017
    Report Date
    June 7, 2017
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROPHYLACTIC GENERATOR REPLACEMENT SURGERY, THE SURGEON NOTED SOME CREAM-COLORED DISCOLORATION IN THE LEAD NEAR THE LEAD PIN. FOLLOW UP WITH THE COMPANY REPRESENTATIVE REVEALED THAT THE SURGEON WAS UNSURE, BUT SPECULATED THAT THERE WAS A CREAM-COLORED FLUID INSIDE THE INSULATION. THERE WERE NO INFECTIONS NOTED OR OBSERVED. THE SURGEON INSPECTED ALL OF THE VISIBLE LEAD FOR DAMAGE AND NONE WAS OBSERVED. MULTIPLE DIAGNOSTIC TESTS WERE RAN AND ALL WERE WITHIN NORMAL LIMITS. THE SURGEON DETERMINED THAT THE LEAD COULD BE LEFT IN. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400407 LEAD MODEL 302 LEAD LYJ CYBERONICS - HOUSTON 302-20 200936

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR