BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1854573 · Received September 9, 2010

    Report

    Report Number
    1644487-2010-02061
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS BEING REFERRED FOR LEAD AND GENERATOR REVISION DUE TO A LEAD FRACTURE AND UPGRADE TO NEWER MODEL OF PULSE GENERATOR. THE PATIENT WAS SAID TO HAVE HAD HIGH LEAD IMPEDANCE SEEN ON DIAGNOSTIC TESTS PERFORMED A FEW WEEKS PRIOR TO THE REPORT. THE PATIENT WAS REFERED FOR CHEST X-RAYS, WHICH WERE SAID TO HAVE SHOWN A LEAD FRACTURE AND WAS THEN REFERRED TO THE SURGEON FOR REVISION SURGERY. THE X-RAYS HAVE NOT YET BEEN SENT TO THE MANUFACTURER FOR REVIEW. THERE WAS NO KNOWN PATIENT TRAUMA OR MANIPULATION PRIOR TO THE LEAD BREAK. THE PHYSICIAN STATED THE PATIENT IS ACCIDENT PRONE, BUT THERE'S NO REPORTED TRAUMA. A SEARCH IN THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE INDICATED THAT THE LAST KNOWN DIAGNOSTICS PERFORMED ON (B)(6) 2009 WERE WITHIN NORMAL LIMITS. THE EXPLANTED PULSE GENERATOR AND LEAD PORTIONS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE LEAD ANALYSIS HAS YET TO BE COMPLETED. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200772

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR