BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2965173 · Received February 15, 2013

    Report

    Report Number
    1644487-2013-00424
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PRODUCT ANALYSIS OF THE EXPLANTED GENERATOR FOUND THAT THERE WAS NO LOW BATTERY AND NO IFI, NEOS, OR EOS WARNINGS WERE OBSERVED. THE HIGH IMPEDANCE ALLEGATION WAS NOT DUPLICATED IN THE LAB. RESULTS OF DIAGNOSTIC TESTING INDICATED THE DEVICE WAS OPERATING PROPERLY. ELECTRICAL TEST SHOWED THAT THE PULSE GENERATOR WAS OPERATING WITHIN SPECIFICATION. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 50.470% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WOULD GET A GENERATOR REPLACEMENT DUE TO IT BEING AT END OF SERVICE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE REPLACEMENT SURGERY WAS DUE TO THE VAGAL NERVE STIMULATOR MALFUNCTION WITH HIGH LEAD IMPEDANCE AND A PRESUMED ELECTRODE FRACTURE. THE EXPLANTED LEAD WAS DISCARDED, BUT THE GENERATOR WAS RETURNED. THE FULL REVISION SURGERY TOOK PLACE ON (B)(6) 2013. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE LAST DIAGNOSTIC RESULTS AVAILABLE ARE FROM (B)(6) 2009 FROM THE PROGRAMMING HISTORY DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66851 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1409

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR