BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2230481 · Received August 12, 2011

    Report

    Report Number
    1644487-2011-01843
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 20, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURES, UNK IF ABOVE OR BELOW PRE-VNS BASELINE OR IF RELATED TO VNS. PT HAD A PROPHYLACTIC GENERATOR REPLACEMENT. THE GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT PRODUCT ANALYSIS HAS BEEN COMPLETED ON THE PATIENT'S GENERATOR. IN THE PA 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. MAGNET ACTIVATIONS PERFORMED DURING OUTPUT MONITORING TEST (AT A DISTANCE OF ONE-INCH, SPACER BLOCK, FROM GENERATOR), DEMONSTRATE THE APPROPRIATE MAGNET OUTPUT FOR THE PROGRAMMED SETTINGS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 014460

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention