BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2903632 · Received January 9, 2013

    Report

    Report Number
    1644487-2013-00106
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    August 1, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD AN INCREASE IN SEIZURE RELATED TO THE GENERATOR BEING AT END OF SERVICE. IT IS UNKNOWN IF THE INCREASE IN SEIZURES WERE ABOVE OR BELOW BASELINE. THE GENERATOR WAS EXPLANTED AND WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING PRODUCT ANALYSIS 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 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 0.69 YEARS REMAINING BEFORE THE NEOS FLAG WOULD BE SET. HOWEVER, AN INCOMPLETE PROGRAMMING HISTORY (TWO TWO-YEAR GAPS) 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 PRODUCT ANALYSIS 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 GENERATOR WAS DETERMINED TO NOT BE AT END OF SERVICE AND STILL ABLE TO DELIVER THE INTENDED THERAPY. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11710 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 012246

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention