BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL

    MDR report key: 1102476 · Received August 8, 2008

    Report

    Report Number
    1644487-2008-01814
    Event Type
    Injury
    Date Received
    August 8, 2008
    Report Date
    July 1, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE. MAJOR P, THIELE EA, VAGUS NERVE STIMULATION FOR INTRACTABLE EPILEPSY IN TUBEROUS SCLEROSIS COMPLEX, EPILEPSY BEHAV (2008), DOI: 10.1016/J.YEBEH.2008.04.001.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD THEIR VNS EXPLANTED FOR AN ACUTE WOUND INFECTION AFTER IMPLANTATION. THE PT WAS FOUR YEARS OLD AND DEVELOPED AN ACUTE WOUND INFECTION WHO HAD A TENDENCY TO SCRATCH THE SITE AFTER IMPLANTATION. THE COMPLICATION RESOLVED FOLLOWING ANTIBIOTIC TREATMENT. THE INFO WAS RECEIVED FROM AN ARTICLE. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADDITIONAL DETAILS SURROUNDING THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention