BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1790304 · Received August 6, 2010

    Report

    Report Number
    1644487-2010-01787
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE PROPHYLACTIC GENERATOR REPLACEMENT SURGERY, THAT WHEN THE SURGEON CONNECTED THE EXISTING LEAD TO THE NEW GENERATOR, A SUBSEQUENT SYSTEM DIAGNOSTIC TEST REVEALED HIGH LEAD IMPEDANCE, IMPEDANCE GREATER THAN 10,000 OHMS. THE SURGEON REMOVED THE NEW GENERATOR AND CONNECTED THE OLD GENERATOR AND HIGH LEAD IMPEDANCE RESULTED FROM ANOTHER SYSTEM DIAGNOSTIC TEST. THE SURGEON THEN OPTED TO REPLACE THE LEAD. THE EXPLANTED LEAD AND GENERATOR WERE DISCARDED BY THE HOSPITAL STAFF AND ARE THEREFORE, NOT AVAILABLE TO BE RETURNED TO MFR FOR ANALYSIS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE TREATING PHYSICIAN HAVE BEEN MADE, BUT NO ADDITIONAL INFO HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 011114

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR