BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2190941 · Received July 29, 2011

    Report

    Report Number
    1644487-2011-01724
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    January 1, 2009
    Report Date
    July 8, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE GENERATOR WAS FOUND TO BE AT END OF SERVICE 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.

    Description of Event or Problem · 1

    ON (B)(6), 2011, CLINIC NOTES FROM A VNS TREATING PHYSICIAN WERE RECEIVED THROUGH CASE MANAGEMENT. REVIEW OF THE CLINIC NOTES DATED (B)(6), 2011 REVEALED THAT THE PT HAS BEEN EXPERIENCING A GRADUAL INCREASE IN SEIZURES OVER THE PAST 1.5 TO 2 YEARS. DIAGNOSTIC TESTS WERE RUN WHICH SHOWED THAT THE VNS WAS AT END OF SERVICE. THE PT WAS REFERRED FOR BATTERY REPLACEMENT SURGERY. CLINIC NOTES DATES (B)(6), 2011 REPORT THAT ALTHOUGH THE PT'S SEIZURES FREQUENCY HAS INCREASED, HER SEIZURES ARE BRIEFER, LESS INTENSE, AND MANY OF THEM ARE ABORTED WITH VNS MAGNET ACTIVATION. CLINIC NOTES DATED (B)(6), 2010 STATE THAT THE PT HAS BEEN AVERAGING ABOUT 10 OR 11 SEIZURES PER MONTH WHICH IS AN INCREASE IN HER SEIZURE FREQUENCY OVER THE PAST 9 MONTHS WERE SHE WAS AVERAGING BETWEEN 2 AND 4 SEIZURES PER MONTH. THE PHYSICIAN THEN SAYS THAT THIS IS STILL BETTER THAN ABOUT A YEAR AGO WHEN SHE WAS AVERAGING 40-41 SEIZURES PER MONTH. EVEN THOUGH PROGRAMMING HISTORY WAS NOT AVAILABLE FROM 2007 THROUGH PRESENT TIME, A WORST CASE BLC WAS PERFORMED WHICH SHOWED NEGATIVE YEARS UNTIL ERI = YES. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFO FROM THE PHYSICIAN HAVE BEEN TO NO AVAIL THUS FAR. THE PT IS SCHEDULED FOR BATTERY REPLACEMENT SURGERY IN (B)(6) 2011. WHEN ADDITIONAL INFO IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6), 2011 ADDITIONAL INFORMATION WAS RECEIVED WHEN THE MANUFACTURER'S CONSULTANT REPORTED THAT HE SHIPPED THE EXPLANTED GENERATOR TO THE MANUFACTURER FOR PRODUCT ANALYSIS THAT DAY. THE GENERATOR WAS RECEIVED ON (B)(6), 2011 FOR PRODUCT ANALYSIS THAT HAS NOT YET BEEN COMPLETED. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6), 2011, IT WAS DISCOVERED THAT THE VNS PATIENT WENT FOR BATTERY REPLACEMENT DUE TO THE DEVICE NEARING END OF SERVICE. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN ARE UNDERWAY BUT THE GENERATOR HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 012704

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention