BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1132603 · Received August 21, 2008

    Report

    Report Number
    1644487-2008-01977
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    January 1, 2000
    Report Date
    July 29, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE REFERENCE: EPILEPSIA, 42(1): 133-135, 2001. DEEP WOUND INFECTION AFTER VAGUS NERVE STIMULATOR IMPLANTATION: TREATMENT WITHOUT REMOVAL OF THE DEVICE. ORTLER, M, ET AL. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR, AND LEAD PRIOR TO DISTRIBUTION. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A PT DEVELOPED AN INFECTION AT THE ELECTRODE INCISION SITE AFTER IMPLANTATION OF THE VNS THERAPY SYSTEM. THE INFECTION WAS COMPLICATED BY THE PT CONTINUING TO SHAVE HIS NECK AFTER THE SURGERY. THE PT RECOVERED AND NO DEVICES WERE EXPLANTED, HOWEVER; THE PT HAD WOUND DEBRIDEMENT UNDER GENERAL ANESTHESIA AND ALSO RECEIVED INTRAVENOUS ANTIBIOTICS. THE PT ALSO UNDERWENT DAILY DRESSING CHANGES AND WOUND PACKING. AFTER THE WOUND WAS SUFFICIENTLY HEALED WITH GRANULATION TISSUE, THE WOUND WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 13435C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention