BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEAD MODEL 302

    MDR report key: 696998 · Received April 6, 2006

    Report

    Report Number
    1644487-2006-00175
    Event Type
    Other
    Date Received
    April 6, 2006
    Date of Event
    January 30, 2006
    Report Date
    March 7, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS HOSPITALIZED FOR TREATMENT OF INFECTION AT NECK INCISION SITE APPROX ONE MONTH AFTER BEING REIMPLANTED WITH THE VNS THERAPY SYSTEM. THE INFECTION WAS REPORTEDLY TREATED WITH AN I&D AND ANTIBIOTICS. THE PT WAS DISCHARGED WITH A PRESCRIPTION FOR ORAL ANTIBIOTIC THERAPY. THE PT IS CURRENTLY RECEIVING VNS THERAPY AND NO FURTHER INTERVENTION IS PLANNED. AT THE TIME OF RE-IMPLANT SURGERY, BOTH PREOPERATIVE AND INTRAOPERATIVE ANTIBIOTICS WERE UTILIZED; HOWEVER, NO POSTOPERATIVE COURSE OF ANTIBIOTIC THERAPY WAS PRESCRIBED. THE NCP SYSTEM TUNNELING TOOL WAS REPORTEDLY USED AS A SINGLE-USE-ONLY DEVICE FOR THE PROCEDURE. THE PT HAD NOT UNDERGONE ANY OTHER SURGICAL OR DENTAL PROCEDURES OR INVASIVE MONITORING POST RE-IMPLANT, BUT HAD UNDERGONE EXPLANT SURGERY 12 WEEKS PRIOR, ALSO DUE TO INFECTION (REF MEDWATCH REPORT 1644487-2005-00646). THE PT IS NOT IMPLANTED WITH ANY OTHER DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ LYJ CYBERONICS, INC. 302-20 1119

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other