BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4232857 · Received November 6, 2014

    Report

    Report Number
    1644487-2014-02954
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 13, 2014
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REFERRED FOR PROPHYLACTIC GENERATOR REPLACEMENT DUE TO THE VNS BEING ¿OLDER¿ AND WORSENED SEIZURES. CLINIC NOTES DATED (B)(6) 2014 REPORTED THAT THE PATIENT HAD "A FEW BACK TO BACK SEIZURES WITH PROLONGED POST-ICTAL PERIOD.¿ VNS SETTINGS WERE ADJUSTED. HOWEVER, THERE DID NOT APPEAR TO BE A DIRECT ALLEGATION OF WORSENED SEIZURES IN THE CLINIC NOTES. FOLLOW-UP WITH THE TREATING PHYSICIAN REVEALED THAT THE WORSENED SEIZURES WERE FIRST OBSERVED ON (B)(6) 2014. THE PATIENT EXPERIENCED INCREASED SEIZURE FREQUENCY AND DURATION. IN (B)(6) 2014, THE PATENT WAS EXPERIENCING ONE TO TWO SEIZURES DAILY LASTING 10-20 SECONDS. THE PATIENT THEN BEGAN EXPERIENCING ONE TO THREE SEIZURES LASTING 10-40 SECONDS. PRIOR TO VNS IMPLANT, THE PATIENT WAS EXPERIENCING APPROXIMATELY 90+ SEIZURES PER MONTH. IN (B)(6) 2014, THE PATIENT WAS EXPERIENCING APPROXIMATELY 30-90 PER MONTH. THE PHYSICIAN FELT THAT THE WORSENED SEIZURES MAY HAVE BEEN RELATED TO THE AGE OF THE STIMULATOR. THERE WERE NO EXTERNAL CAUSAL FACTORS THAT ARE BELIEVED TO HAVE CONTRIBUTED TO THE WORSENED SEIZURES. THE GENERATOR REPLACEMENT SURGERY OCCURRED ON (B)(6) 2014. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER. HOWEVER, ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS WAS COMPLETED ON THE GENERATOR. IN THE 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. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713482 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 010093

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention