BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2052538 · Received April 11, 2011

    Report

    Report Number
    1644487-2011-00763
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    September 21, 2010
    Report Date
    March 16, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, CLINIC NOTES FROM A VNS TREATING PHYSICIAN WERE RECEIVED. REVIEW OF THE CLINIC NOTES DATED (B)(6) 2010 REPORT THAT THE VNS PT WAS EXPERIENCING OBSTRUCTIVE SLEEP APNEA. SINCE VNS THERAPY WAS INITIATED, THE PT'S FREQUENCY OF SEIZURES HAS DECREASED; CURRENTLY THE PT EXPERIENCES AN AVERAGE OF 2 A WEEK. SINCE THE PT'S LAST VISIT ON (B)(6) 2010, THE PT HAS HAD 5 SEIZURES. THE PT'S MAGNET WAS USED DURING EACH EPISODE AND REPORTED AS SUCCESSFULLY ABORTING THE SEIZURES EACH TIME. THE PT EXPERIENCED A BRIEF COUGH AFTER THE SIGNAL CURRENT WAS INCREASED ON (B)(6) 2010. GOOD FAITH ATTEMPTS FOR MORE INFO HAVE BEEN TO NO AVAIL THUS FAR. IF ADDITIONAL INFO IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 LYJ CYBERONICS, INC. 104 201114

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention