BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2860536 · Received December 6, 2012

    Report

    Report Number
    1644487-2012-03211
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    August 8, 2012
    Report Date
    November 6, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 FOUND THAT TYPICALLY THE PATIENT'S GENERALIZED TONIC-CLONIC SEIZURES OCCUR SPORADICALLY, WITH THE LAST ONE BEING A MONTH AND A HALF PRIOR. HOWEVER, IN RECENT MONTHS THE PATIENT'S GRANDMAL SEIZURES HAVE BECOME MORE FREQUENT AND WERE NOW OCCURING ON AVERAGE TWICE A MONTH. THE PHYSICIAN SAW ONE OF THE SEIZURES ON TAPE AND NOTED THAT IT SHOWED A PROGRESSION FROM A SIGN OF 4 (RIGHT ARM FLEXED) TO A GENERALIZED TONIC-CLONIC SEIZURE WITH FOAMING AT THE MOUTH. HE STATED THAT IT WAS A CLEAR SECONDARY GENERALIZED EPILEPTIC SEIZURE. PER THE NOTES, THE PATIENT STATED THAT SHE WAS NOT EXPERIENCING HER OTHER SEIZURE TYPES RECENTLY. THE NOTES STATE THAT THE PHYSICIAN INTERROGATED THE VNS DEVICE AND FOUND THAT IT SHOWED THE END OF SERVICE NOTIFICATION. HE THEREFORE PLACED A REFERRAL TO HAVE THE BATTERY REPLACED AS SOON AS POSSIBLE AND THE PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6), 2012. PRODUCT ANALYSIS ON THE RETURNED GENERATOR FOUND THAT THERE WERE 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'S DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE END OF SERVICE ALLEGATION WAS NOT CONFIRMED IN PRODUCT ANALYSIS. HOWEVER, THE NEAR-END-OF-SERVICE (NEOS) INDICATOR WAS SET TO YES. BASED ON THE ELECTRICAL TEST RESULTS, THE DEVICE EXHIBITED CURRENT CONSUMPTION RATES THAT ARE WITHIN SPECIFICATION, THEREBY DEMONSTRATING NORMAL BATTERY DEPLETION TO A NEAR-END-OF-SERVICE (NEOS) CONDITION. A BATTERY LIFE ESTIMATION RESULTED IN 0.60 YEARS REMAINING BEFORE THE NEOS FLAG WOULD BE SET. HOWEVER, AN INCOMPLETE PROGRAMMING HISTORY INDICATES THE ESTIMATION DOES NOT USE ALL THE DATA REQUIRED TO MAKE AN ACCURATE ESTIMATION. THEREFORE, THE ELECTRICAL PERFORMANCE OF THE GENERATOR, AS MEASURED IN THE PA LAB, WILL BE USED TO CONCLUDE THAT NO ANOMALIES EXIST AND THE NEOS CONDITION IS AN EXPECTED EVENT. 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. THE RELATIONSHIP OF THE INCREASE IN SEIZURES TO PRE-VNS BASELINE LEVELS IS UNKNOWN. THE RELATIONSHIP OF THE INCREASE IN SEIZURES TO VNS THERAPY IS ALSO UNKNOWN. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    A PROGRAMMING HISTORY REVIEW FOUND THE PATIENT'S SETTINGS AND DIAGNOSTIC RESULTS FROM (B)(6) 2012 AND (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 015709

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention