BEUDAMED
    FDA Adverse Event Other Summary report: N

    VNS THERAPY PULSE MODEL 102 GENERATOR

    MDR report key: 688723 · Received March 16, 2006

    Report

    Report Number
    1644487-2006-00140
    Event Type
    Other
    Date Received
    March 16, 2006
    Date of Event
    January 1, 2006
    Report Date
    February 14, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PATIENT DEVELOPED AN INFECTION AT THE CHEST INCISION SITE POST-IMPLANT. THE PATIENT REPORTED THAT THE HAD TO BE SEEN IN HOSPITAL EMERGENCY ROOM DUE TO THE INFECTION AT THE INCISION SITE. TREATING PHYSICIAN INDICATED THAT THE PATIENT CAUSED THE EVENT AND THAT THE EVENT WAS A RESULT OF THE PATIENT PICKING AT THE INCISION SITE. FURTHER FOLLOW-UP WITH TREATING PHYSICIAN REVEALED THAT THERE WAS NO INFECTION PRESENT AT EITHER THE PULSE GENERATOR/POCKET AREA OR THE BIPOLAR LEAD/CERVICAL AREA AND THAT ONLY ERYTHEMA WAS PRESENT; HOWEVER, NO CULTURES WERE TAKEN. THE PATIENT WAS PRESCRIBED A PROPHYLACTIC COURSE OF ANTIBIOTIC THERAPY. DURING INITIAL IMPLANT SURGERY, PREOPERATIVE ANTIBIOTICS WERE PRESCRIBED, BUT INTRAOPERATIVE ANTIBIOTIC THERAPY WAS NOT UTILIZED DURING THE SURGERY. ADDITIONALLY, POSTOPERATIVE ANTIBIOTICS WERE NOT PRESCRIBED. THE NCP SYSTEM TUNNELLING TOOL WAS USED AS A SINGLE-USE-ONLY DEVICE DURING THE IMPLANT SURGERY. THE PATIENT HAD NOT UNDERGONE ANY SURGICAL OR DENTAL PROCEDURES OR INVASIVE MONITORING POST IMPLANT OR THREE MONTHS PRE-IMPLANT AND IS NOT IMPLANTED WITH ANY OTHER DEVICES. AT FOLLOW-UP VISIT, THE INCISION SITES WERE STILL RED IN SOME AREAS, BUT GETTING BETTER. THE INCISIONS WERE REPORTEDLY HEALING WELL AND STIMULATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE MODEL 102 GENERATOR MUZ LYJ CYBERONICS, INC. 102 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other