BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4103147 · Received September 19, 2014

    Report

    Report Number
    1644487-2014-02407
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    January 1, 2008
    Report Date
    August 21, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS PROGRAMMED OFF ON (B)(6) 2008 AND THAT CLINIC NOTES INDICATE THE PATIENT'S SEIZURES MAY BE ESCALATING. REVIEW OF DEVICE PROGRAMMING HISTORY FOUND THAT THE PATIENT WAS RECEIVING DEVICE STIMULATION (2.5MA) AS OF (B)(6) 2011. NO FURTHER INFORMATION WAS AVAILABLE PAST THAT DATE. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE CLINIC NOTES HAVE NOT BEEN RECEIVED BY MANUFACTURER FOR REVIEW AND THE LAST KNOWN TREATING PHYSICIAN INDICATED THAT THE PATIENT IS NO LONGER BEING SEEN BY THAT OFFICE AND THEY HAVE NOT FURTHER INFORMATION TO PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582067 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 016274

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention