BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1905625 · Received November 19, 2010

    Report

    Report Number
    1644487-2010-02628
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 22, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT WAS HAVING AN INCREASE IN SEIZURES FOR THE 4-6 WEEKS PRIOR TO THE REPORT. THE PT'S PULSE GENERATOR WAS NOT AT AN EOS CONDITION, BUT THE PT WAS REFERRED FOR GENERATOR REPLACEMENT DUE TO THE INCREASE IN SEIZURES. THE PT HAS HAD THE PULSE GENERATOR REPLACED, BUT THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. A SEARCH PERFORMED IN THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE INDICATES THAT THE LAST KNOWN DIAGNOSTICS WERE PERFORMED ON (B)(4) 2008, WHICH WERE WITHIN NORMAL LIMITS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 8350

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention