BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3170255 · Received June 14, 2013

    Report

    Report Number
    1644487-2013-01788
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 22, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE VNS PATIENT HAD UNDERGONE A GENERATOR REPLACEMENT ON (B)(6) 2013 DUE TO PATIENT ¿COMPLAINING OF PAIN¿. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS ON (B)(6) 2013. PRODUCT ANALYSIS IS CURRENTLY UNDERWAY AND HAS NOT YET BEEN COMPLETED. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS ON THE EXPLANTED GENERATOR WAS COMPLETED ON (B)(4) 2013. THE SEPTUM WAS NOT CORED, THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH BODY FLUIDS. 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. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271686 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 016389

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention