BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2230476 · Received August 12, 2011

    Report

    Report Number
    1644487-2011-01841
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. 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. 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 PT FELT THAT HER VNS WAS NOT WORKING. THE PT HAS BEEN FEELING A DECREASE SENSATION DURING STIMULATION. THE PT ALSO REPORTED A SLIGHT INCREASE IN SEIZURE FREQUENCY. THE PT FEELS THAT THEIR GENERATOR HAS REACHED END OF SERVICE. THE PHYSICIAN FEELS THAT INCREASE IN FREQUENCY IS DUE TO THE GENERATOR APPROACHING END OF SERVICE. THE GENERATOR IS NOT AT END OF SERVICE AS ERI=NO. THE PT HAD A PROPHYLACTIC GENERATOR REPLACEMENT. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THE PATIENT'S INCREASE IN SEIZURES WERE BELOW BASELINE. THERE WAS NO CAUSAL OR CONTRIBUTORY MEDICATION OR PROGRAMMING CHANGES THAT PRECEDED THE INCREASE IN SEIZURES NOR REPORTED MANIPULATION OR TRAUMA. SINCE GENERATOR REPLACEMENT THE PATIENT IS DOING MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 11003

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention