BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 3101747 · Received May 9, 2013

    Report

    Report Number
    1644487-2013-01305
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    April 18, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. 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. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2013 DUE TO PROPHYLACTIC REASONS AND AN INCREASE IN SEIZURES. THE PHYSICIAN LATER REPORTED THAT THE INCREASE IN SEIZURES WAS FIRST OBSERVED IN (B)(6) 2012. THE PHYSICIAN STATED IT IS UNKNOWN WHAT THE RELATIONSHIP OF THE INCREASE IN SEIZURES IS TO VNS. THE PATIENT UNDERWENT MULTIPLE MEDICATION ADJUSTMENTS AS AN INTERVENTION. IT WAS STATED THAT THE SEIZURES INCREASED WITH HER BASELINE SETTINGS AND CONTINUE TO OCCUR AFTER GENERATOR REPLACEMENT SURGERY AND BACK TO BASELINE SETTINGS. ATTEMPTS WERE MADE FOR THE RETURN OF THE EXPLANTED GENERATOR FOR PRODUCT ANALYSIS BUT IT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204310 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 5757

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention