BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1311560 · Received February 10, 2009

    Report

    Report Number
    1644487-2009-00215
    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 OXACILLIAN-RESISTANT S. AUREUS. THE PT ALSO HAD A STITCH ABSCESS THAT LED TO DRAINAGE AND WAS TREATED WITH CEPH, VANCO/CTX AND PO CIPRO. 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