BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2250798 · Received September 16, 2011

    Report

    Report Number
    1644487-2011-02189
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    March 7, 2011
    Report Date
    August 23, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT #1 INADVERTENTLY DID NOT PROVIDE THE EXPLANT DATE FOR THE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THE GENERATOR REPLACEMENT WAS DONE PROPHYLACTICALLY AND FOR PATIENT COMFORT AS IT WAS BELIEVED THE PAINFUL STIMULATION WAS RELATED TO THE GENERATOR NEARING END OF SERVICE. THE PATIENT IS NOT HAVING AN INCREASE IN SEIZURES. THE PATIENT REPORTS THAT SHE IS HAVING AN INCREASE IN SEIZURES BUT THE FAMILY AND PHYSICIAN CONFIRM THAT SHE IS NOT. THE PATIENT IS HAVING MORE NOCTURNAL SEIZURES BUT THEY ARE WITHIN NORMAL RANGES OF FREQUENCY AND SHE DOES NOT CONSIDER IT AN INCREASE. THE PATIENT HAD THEIR GENERATOR REPLACED. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN ARE IN PROCESS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS BEING EXPLANTED DUE TO LACK OF EFFICACY. FURTHER INFORMATION WAS RECEIVED THAT INDICATED THAT THE PATIENT WAS EXPERIENCING PAINFUL ERRATIC STIMULATION AND PAIN. THE PAIN WAS BELIEVED TO BE DUE TO THE PATIENT'S SIGNIFICANT WEIGHT LOSS DUE TO A GALLBLADDER INFECTION, NOT RELATED TO VNS, AND THE POTENTIAL THAT THE GENERATOR MAY HAVE MIGRATED. THE PATIENT WENT TO SEE A SURGEON AND HE DISABLED THE DEVICE FOR A TIME BUT THEN TURNED IT BACK TO THE PREVIOUS SETTINGS WITH NO ADDITIONAL REPORTED ISSUE. THE PLAN IS TO CONTINUE WITH THE GENERATOR REPLACEMENT WHICH AS NOT OCCURRED TO DATE. THE PATIENT HAS ALSO HAD AN INCREASE IN NOCTURNAL SEIZURES, UNKNOWN IF ABOVE OR BELOW BASELINE, WHICH WAS TREATED WITH AN INCREASE IN MEDICATION DOSE. AT A LATER APPOINTMENT IT WAS REPORTED THAT HER SEIZURES WERE DOING WELL. 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 GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IN THE PRODUCT ANALYSIS 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. 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 GENERATOR LYJ CYBERONICS INC 102 013636

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention