BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2854718 · Received December 3, 2012

    Report

    Report Number
    1644487-2012-03174
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 2, 2012
    Report Date
    November 5, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS BEEN DOING WELL SINCE REPLACEMENT. PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. 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. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE DATA IN THE DIAGACCUM CONSUMED MEMORY LOCATIONS REVEALED THAT 97.971% OF THE BATTERY HAD BEEN CONSUMED. THE BATTERY, 2.747 VOLTS, SUGGESTS AN IFI CONDITION. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT SEIZURE HAVE BEEN MORE SEVER AND PROMINENT. THE PATIENT IS NOW HAVING SEIZURES EVERYDAY WHICH CONSISTS OF GENERALIZED SHAKING EPISODES SOME LASTING 10 MINUTES. THE PATIENT HAD TO HAVE DIASTAT A COUPLE TIMES WHICH HELPED. THE PATIENT WAS HAVING MORE CRYING OUT, HEAD DROPS AND SHAKING BUT THIS OCCURS OCCASIONAL AS PART OF HIS SEIZURE PATTERN. THERE WERE NO MEDICATION CHANGES AND NOT INJURIES. THE PHYSICIAN FELT THE SEIZURES MAY BE RELATED TO THE GENERATOR NEARING END OF SERVICE AND LOSS OF THERAPY. HOWEVER, BASED ON DIAGNOSTICS THE GENERATOR WAS STILL DELIVERING THE INTENDED THERAPY. THE PATIENT HAD A PROPHYLACTIC GENERATOR REPLACEMENT. THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201065

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR