BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2352568 · Received November 30, 2011

    Report

    Report Number
    1644487-2011-02889
    Event Type
    Injury
    Date Received
    November 30, 2011
    Date of Event
    February 4, 2011
    Report Date
    November 7, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VAGUS NERVE STIMULATION FOR EPILEPSY: THE NORTE-DAME HOSPITAL EXPERIENCE BY QIABI, M., BOUTHILLIER, A., CARMANT, L., NGUYEN, D.K. CAN. J. NEUROL. SCI. 2011: 38: 902-908.

    Description of Event or Problem · 1

    FOLLOW UP WAS PERFORMED WITH THE AUTHOR OF THE ARTICLE HOWEVER HE WILL NOT BE ABLE TO PROVIDE ANY ADDITIONAL INFORMATION DUE TO CONFIDENTIALITY AGREEMENTS HE SIGNED WHEN GATHERING THE DATA FOR THE ARTICLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE ENTITLED "VAGUS NERVE STIMULATION FOR EPILEPSY: THE NOTRE-DAME HOSPITAL EXPERIENCE" THAT ONE PATIENT DEVELOPED A MINOR SCAR INFECTION AT THE ELECTRODE SITE TWELVE MONTHS AFTER DEVICE IMPLANT. THE INFECTION RESOLVED WITH ANTIBIOTIC TREATMENT AND DID NOT REQUIRE DEVICE REMOVAL. 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 UNK GENERATOR LYJ CYBERONICS, INC. ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention