BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3101969 · Received May 9, 2013

    Report

    Report Number
    1644487-2013-01306
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    January 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE GENERATOR WAS RETURNED FOR ANALYSIS ON (B)(4) 2013. THE GENERATOR ANALYSIS WAS COMPLETED ON (B)(4) 2013. AN END-OF-SERVICE WARNING MESSAGE WAS VERIFIED IN THE PA LAB AND FOUND TO BE ASSOCIATED WITH THE PULSE DISABLED BY THE PULSE GENERATOR. THE POST BURN-IN ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. OTHER THAN THE NOTED CONDITION, THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT A GENERATOR REPLACEMENT BECAUSE THE BATTERY WAS DEAD. IT WAS STATED THAT THE EXPLANTED GENERATOR WAS DISCARDED BY THE OR TECH AND THEREFORE COULD NOT BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS. ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN REGARDING THE INCREASE IN SEIZURES, HE DID NOT PROVIDE ANY FURTHER INFORMATION.

    Description of Event or Problem · 1

    ON APRIL 22, 2013, CLINIC NOTES DATED (B)(6) 2013 REVEALED THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURE ACTIVITY. THE PATIENT'S VNS WAS CHECKED AND THE BATTERY WAS FOUND TO BE AT END OF SERVICE. THE PATIENT WAS REFERRED FOR SURGERY. THE PROGRAMMING HISTORY DATABASE WAS SEARCHED AND A SYSTEM DIAGNOSTICS TEST PERFORMED ON (B)(6) 2012 SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/IMPEDANCE VALUE=2360OHMS/EOS=OK. HOWEVER, ON (B)(6) 2010, A SYSTEM DIAGNOSTICS WAS PERFORMED WHICH SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/IMPEDANCE VALUE=2183OHMS/TIME TILL EOS=2.5 YEARS, THE 2.5 YEARS REMAINING MEANS THAT IT IS LIKELY THAT THE GENERATOR IS CURRENTLY NEARING EOS OR AT EOS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203557 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201095

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR