BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3024082 · Received March 27, 2013

    Report

    Report Number
    1644487-2013-00841
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE GENERATOR WAS FOUND TO BE AT END OF SERVICE AND THE FAILURE TO PROGRAM EVENT WAS DUPLICATED IN THE PA LABORATORY AND DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY DEPLETION, BASED ON THE BATTERY LIFE ANALYSIS AND ELECTRICAL TEST RESULTS. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS; THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ADDITIONAL INFORMATION WAS RECEIVED WHEN IT WAS REPORTED THAT THE LEAD IMPEDANCE AFTER SURGERY WAS "OK" AND THAT THE GENERATOR HAD BEEN REPLACED DUE TO BATTERY DEPLETION. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS ON (B)(6) 2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE VNS PATIENT WAS BEING REFERRED FOR A "POTENTIAL COMPLETE REVISION" DUE TO THE PATIENT HAVING PAINFUL SHOCKS AND THEY THOUGHT THE DEVICE MAY BE MALFUNCTIONING. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN WERE UNSUCCESSFUL. ON (B)(6) 2013, IT WAS STATED THAT THE PATIENT¿S VNS WAS UNABLE TO BE INTERROGATED DURING SURGERY. SYSTEM DIAGNOSTIC TESTS AFTER THE GENERATOR WAS REPLACED SHOWED RESULTS WITHIN NORMAL LIMITS SO NO LEAD REPLACEMENT WAS PERFORMED. IT WAS STATED THAT THE PATIENT'S VNS WAS BELIEVED TO BE AT END OF SERVICE WHICH IS WHY IT COULD NOT BE INTERROGATED. ATTEMPTS HAVE BEEN MADE FOR RETURN OF THE EXPLANTED GENERATOR FOR PRODUCT ANALYSIS BUT IT HAS NOT BEEN RECEIVED TO DATE. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 0 YEARS REMAINING UNTIL ERI=YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127045 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 013755

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention