BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1993857 · Received February 11, 2011

    Report

    Report Number
    1644487-2011-00244
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    August 8, 2008
    Report Date
    January 13, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD TWO GRAND MAL SEIZURES AND WAS ADMITTED INTO THE HOSPITAL. THE PT HAD ONLY TWO OTHER GRAND MAL SEIZURES IN HER LIFE. THE PT REPORTED NO CHANGE IN LIFESTYLE OR MEDICATIONS. THE PHYSICIAN BELIEVES THAT THE PT SEIZURES THAT LEAD TO THE HOSPITALIZATION WERE RELATED TO A DEPLETED GENERATOR. THE PT REPORTED THAT SHE FEELS HER SEIZURES ARE WORSE THAN BEFORE VNS. THE PT HAD GENERATOR REPLACEMENT AND THE EXPLANTED GENERATOR HAS BEEN RETURNED TO THE MFR FOR EVAL. PRODUCT ANALYSIS IS PLANNED, BUT HAS NOT BEEN COMPLETED. GOOD FAITH ATTEMPTS TO GAIN MORE INFO 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 200782

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R