BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2870716 · Received December 12, 2012

    Report

    Report Number
    1644487-2012-03314
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. 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. WITH THE PULSE GENERATOR CASE REMOVED AND THE BATTERY STILL ATTACHED TO THE PCB, THE BATTERY MEASURED 1.855 VOLTS, VERIFYING AN EOS CONDITION. WITH THE EXCEPTION FOR CAPACITOR C4 OUT OF SPECIFICATION, THE POST BURN-IN ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THIS IS NOT EXPECTED TO HAVE AN ADVERSE EFFECT ON BATTERY LONGEVITY. THE CAUSE FOR THE OUT OF SPECIFICATION CAPACITOR, C4, (V CPU) VALUE IS LIKELY ASSOCIATED WITH COMPONENT AGING. 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

    ADDITIONAL INFORMATION AS RECEIVED ON (B)(6) 2013 WHEN IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. IT WAS ALSO REPORTED THAT HIGH IMPEDANCE WAS OBSERVED AFTER THE GENERATOR WAS REPLACED (REPORTED ON MFR. REPORT # 1644487-2013-00472). IT WAS REPORTED THAT THE EXPLANTED GENERATOR COULD NOT BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS AS THE HOSPITAL REQUIRES A SIGNED RELEASE FROM THE PATIENT, HOWEVER THEY USUALLY DISCARD IT.

    Description of Event or Problem · 1

    ON (B)(6) 2012 CLINIC NOTES WERE RECEIVED DATED (B)(6) 2012 WHICH INDICATED THAT THE PATIENT HAS BEEN COMPLAINING OF INTERMITTENT CHEST WALL PAIN OVERLYING THE VNS FOR THE LAST TWO WEEKS. THE PAIN WAS NON-RADIATING AND INTERMITTENT IN NATURE. INTERROGATION OF THE VNS WAS ATTEMPTED BUT A MESSAGE WAS RECEIVED THAT INDICATED "VBAT LESS THAN EOS THRESHOLD" AND THE GENERATOR IS NOT SUPPLYING STIMULATION. THE PHYSICIAN REPORTED THAT THE VNS IS NOT WORKING PROPERLY AT THIS TIME SO THE PATIENT WOULD BE REFERRED FOR BATTERY REPLACEMENT DUE TO END OF SERVICE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE EXPLANTED GENERATOR WOULD BE RETURNED FOR PRODUCT ANALYSIS. THE EXPLANTED GENERATOR WAS RECEIVED FOR PRODUCT ANALYSIS ON (B)(6) 2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012 WHEN CLINIC NOTES WERE RECEIVED DATED (B)(6) 2012. THE CLINIC NOTES INDICATE THAT HE PATIENT HAS ONE GRAND MAL SEIZURE PER WEEK AND HAS JERKING THROUGH THE DAY THAT IS GETTING WORSE. THE PATIENT'S MOTHER REPORTED THAT THE VNS HAS BEEN TURNED UP AS MUCH AS POSSIBLE BUT THE MAGNET DOESN'T SEEM TO BE WORKING. RECENTLY THE PATIENT HAS HAD NEUROLOGIC REGRESSION WITH BOTH COGNITIVE AND MOTOR REGRESSION. THE VNS WAS NOTED TO BE AT END OF LIFE AND THE PATIENT WAS REFERRED FOR REPLACEMENT OF THE VNS. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 200948

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention