BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2980713 · Received February 27, 2013

    Report

    Report Number
    1644487-2013-00531
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 29, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED VIA CLINICAL NOTES RECEIVED TO THE MANUFACTURER THAT THE PATIENT MAY BE HAVING MORE MILD SEIZURES WITH "ZONING OUT" AND "HEAD DROPS." THE VNS GENERATOR WAS NEARING END OF SERVICE, BUT STILL OPERATING PROPERLY. THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT SURGERY. THE PATIENT HAD GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. THE EXPLANTED GENERATOR HAS BEEN RETURNED AND IS PENDING ANALYSIS. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED THE MILD INCREASE IN SEIZURES WAS FELT TO BE RELATED TO DISEASE PROCESS AND VNS END OF SERVICE. NO ADDITIONAL INTERVENTIONS WERE DONE FOR THE INCREASED SEIZURES OTHER THAN GENERATOR REPLACEMENT. THE LEVEL OF THE SEIZURE INCREASE WAS ABOUT THE SAME AS THE PATIENT'S PRE-VNS BASELINE LEVEL. BOTH OF THE PATIENT'S SEIZURE TYPES WERE INCREASED, BUT THE TYPES WERE NOT SPECIFIED. NO CAUSAL OR CONTRIBUTORY VNS PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDED THE ONSET OF THE SEIZURE INCREASE. ANALYSIS OF THE RETURNED VNS GENERATOR WAS COMPLETED. 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. THE GENERATOR WAS AT END OF SERVICE, WITH THE IFI = YES FLAG DISPLAYED. 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
    84363 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 201224

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention