BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1854601 · Received September 9, 2010

    Report

    Report Number
    1644487-2010-02057
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    June 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES ABOVE BASELINE LEVELS. THE PATIENT STATED THAT THE SEIZURES ARE CURRENTLY WORSE THAN THEY WERE PRIOR TO BEING IMPLANTED WITH VNS. THE PATIENT MENTIONED THAT HE WAS TASERED IN THE CHEST IN (B)(6) 2010. THE PATIENT STATED THAT HE FOLLOWED UP WITH HIS NEUROLOGIST AFTER BEING TASERED, HOWEVER, HE WAS NOT SURE WHETHER OR NOT ANY DEVICE DIAGNOSTICS WERE PERFORMED. GOOD FAITH TO OBTAIN ADDITIONAL INFORMATION FROM THE PATIENT'S NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 200975

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR