BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1760485 · Received July 15, 2010

    Report

    Report Number
    1644487-2010-01635
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    April 28, 2009
    Report Date
    June 18, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INCREASE IN SEIZURES. THE PHYSICIAN ADJUSTED THE PATIENT'S SETTINGS TO HELP ALLEVIATE THE ISSUE. THE PATIENT LATER UNDERWENT GENERATOR REVISION SURGERY, AS INTERROGATION OF THE PATIENT'S DEVICE REVEALED THAT IT WAS AT END OF SERVICE. 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 015852

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention