BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3240223 · Received July 22, 2013

    Report

    Report Number
    1644487-2013-02204
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE GENERATOR WAS RETURNED FOR ANALYSIS. ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2013. 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. 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.

    Description of Event or Problem · 1

    THE PATIENT'S GENERATOR REPLACEMENT SURGERY TOOK PLACE ON (B)(6) 2013. SYSTEM DIAGNOSTICS WERE PERFORMED WITHOUT ERROR AFTER SURGERY AND THE SETTINGS WERE ADJUSTED TO PREVIOUS SETTINGS PER THE PHYSICIAN'S ORDERS. THE DEVICE WAS EXPLANTED PROPHYLACTICALLY AND HAS NOT BEEN RETURNED TO THE COMPANY.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 STATE THAT THE PATIENT IS AT THE PHYSICIAN'S OFFICE FOR A FOLLOW UP DUE TO AN INCREASING NUMBER OF SEIZURES. PER THE PATIENT'S SISTER, IT IS DIFFICULT TO GET THE PATIENT TO RELAX SINCE SHE IS STRESSED OUT OVER A VARIETY OF THINGS. THE PATIENT WAS RECENTLY MARRIED. SHE HAS ALSO HAD SEVERAL FALLS FROM HER SEIZURES AND HIT HER HEAD. THE PATIENT HAS A HISTORY OF HEADACHES AND FEELS THAT HER CURRENT HEADACHE IS NOT DIFFERENT FROM THE ONE BEFORE. ADDITIONALLY, THE PATIENT HAS MEMORY PROBLEMS FROM HER SEIZURES AND MEDICATIONS. THERE HAVE BEEN NO ER VISITS, SURGERY, OR HOSPITALIZATION SINCE THE LAST VISIT. THE PATIENT AND FAMILY BELIEVE HER SEIZURES ARE BETTER CONTROLLED. IT WAS NOTED THAT THE BATTERY INDICATOR SAYS THAT THE PATIENT'S BATTERY LIFE IS NEAR EXPIRATION AND BATTERY REPLACEMENT IS BEING CONSIDERED. A REVIEW OF PROGRAMMING HISTORY WAS PERFORMED; HOWEVER, THE ONLY DIAGNOSTIC DATA IS FROM THE IMPLANT DATE. FOLLOW UP WITH THE PHYSICIAN'S OFFICE FOUND THAT THE INCREASE IN SEIZURES WAS RELATED TO THE PATIENT'S UPCOMING BATTERY REPLACEMENT; HOWEVER, AS THE PATIENT'S BATTERY IS AT THE IFI CONDITION, THE PATIENT SHOULD STILL BE RECEIVING FULL THERAPY. THE NURSE STATED THAT SHE WOULD HAVE THE PHYSICIAN CALL BACK TO DISCUSS THE EVENT AND ANOTHER ATTEMPT WAS MADE; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339644 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202049

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other