BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3062849 · Received April 17, 2013

    Report

    Report Number
    1644487-2013-01041
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    December 1, 2012
    Report Date
    March 21, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. ALTHOUGH THEIR INCREASED SEIZURES CANNOT BE EVALUATED IN THE LABORATORY SETTING, PROPER FUNCTIONALITY OF THE PULSE GENERATOR IN ITS ABILITY TO PROVIDE APPROPRIATE PROGRAMMED OUTPUT CURRENTS CAN BE VERIFIED. IN THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT HAVING A PROPHYLACTIC REPLACEMENT OF THEIR GENERATOR. THE PATIENT'S MOTHER REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE AN INCREASE IN SEIZURES STARTING ON (B)(6) 2012. BEGINNING IN (B)(6) 2013, THE SEIZURE FREQUENCY VARIED. PER PHYSICIAN, THE DEVICE HAD NOT BEEN CHANGED IN 10 YEARS AND WAS PRESUMED TO BE DEAD OR NEARING END OF SERVICE. THE DEVICE WAS NOT INTERROGATED THEREFORE, NO ERI FLAG WAS NOTED AS INDICATED. THE PATIENT DID NOT HAVE A CHANGE IN SEIZURE TYPE AND IT IS UNKNOWN IF IT WAS AN INCREASE OVER THEIR PREVENTS BASELINE RATE. THE PATIENT'S EXPLANTED GENERATOR HAS BEEN RETURNED FOR ANALYSIS. BATTERY STATUS WILL BE CONFIRMED IN PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165420 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 009493

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention