BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1943831 · Received December 28, 2010

    Report

    Report Number
    1644487-2010-02911
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT DURING A STUDY OF 70 VNS PATIENTS, ONE PT EXPERIENCED A POSTOPERATIVE WOUND INFECTION AND THE SYSTEM WAS EXPLANTED IMMEDIATELY. NO ADDITIONAL INFO WAS PROVIDED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention