BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2994438 · Received March 8, 2013

    Report

    Report Number
    1644487-2013-00650
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN INDICATED THAT THE PATIENT WAS SEEN ON (B)(6) 2013 AND WAS "CLEARLY DOING MUCH BETTER" FOLLOWING GENERATOR REPLACEMENT SURGERY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT PATIENT SEIZURES WERE UNEXPLAINABLE WORSE. THE GENERATOR HAD THE BATTERY IFI WARNING TRIGGERED. THE PATIENT HAS BEEN REFERRED FOR A GENERATOR REPLACEMENT. SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A GENERATOR REPLACEMENT. THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETE.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. IN THE PA LAB, THE GENERATOR 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 BATTERY, 2.761 VOLTS AS MEASURED SHOWS AN IFI CONDITION. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 98.128% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN. THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2013 WHERE IT WAS REPORTED THAT HE WAS HAVING MORE PROLONGED SEIZURES WITH CLONIC ACTIVITY. THE PATIENT'S SEIZURES HAVE INEXPLICABLY BEEN WORSENING. THE PATIENT WAS REFERRED FOR A BATTERY REPLACEMENT AND CONTINUED ON HIS MEDICATION WITHOUT CHANGE. THE GENERATOR WAS NOT AT END OF SERVICE BUT THE IFI FLAG WAS OBSERVED. SURGERY FOR A GENERATOR REPLACEMENT IS LIKELY BUT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99717 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2351

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention