BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1311566 · Received February 10, 2009

    Report

    Report Number
    1644487-2009-00221
    Event Type
    Injury
    Date Received
    February 10, 2009
    Date of Event
    January 7, 2009
    Report Date
    January 7, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ELLEN LR, ET. AL. "MANAGEMENT OF VAGAL NERVE STIMULATOR INFECTIONS: DO THEY NEED TO BE REMOVED.?" J NEUROSURG PEDIATRICS 3, 73-78, 2009.

    Description of Event or Problem · 1

    REPORTER INDICATED VIA LITERATURE, A VNS THERAPY PT EXPERIENCED AN INFECTION AT THE GENERATOR SITE AND UNDERWENT EXPLANT SURGERY. CULTURES WERE POSITIVE FOR S. AUREUS. THE PT PRESENTED WITH CHEST DRAINAGE AND CHEST FULLNESS AND WAS TREATED WITH CHEP, VANCO, AND VANCO/RIF. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention