BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 567638 · Received January 25, 2005

    Report

    Report Number
    1644487-2005-00065
    Event Type
    Injury
    Date Received
    January 25, 2005
    Date of Event
    August 28, 2001
    Report Date
    October 26, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE REVIEWING DEVICE TRACKING DATA, MFR BECAME AWARE OF A DEVICE REPLACEMENT SURGERY LESS THAN ONE MONTH AFTER IMPLANT. THE PT UNDERWENT NCP SYSTEM REPLACEMENT, SURGERY DUE TO STAPH INFECTION AT THE PULSE GENERATOR/POCKET AREA. PREOPERATIVE, INTRAOPERATIVE AND POSTOPERATIVE ANTIBIOTICS WERE UTILIZED AT THE TIME OF INITIAL IMPLANT SURGERY AND THE SURGERY LASTED FOR APPROX 2 HOURS. THE NCP SYSTEM TUNNELING TOOL WAS UTILIZED DURING THE INITIAL IMPLANT SURGERY AND WAS USED AS A SINGLE-USE-ONLY INSTRUMENT. THE PT HAD NOT UNDERGONE AND SURGICAL OR DENTAL PROCEDURES OR INVASIVE MONITORING EITHER THREE MONTHS PRE OR POST VNS IMPLANT AND IS NOT IMPLANTED WITH ANY OTHER DEVICES. THE INFECTION WAS TREATED WITH ANTIBIOTICS AND EXPLANT OF BOTH THE LEAD AND GENERATOR. THE PT WAS REIMPLANTED WITH A NEW NCP SYSTEM ON THE SAME DAY THAT THE ORIGINAL NCP SYSTEM WAS EXPLANTED FOR INFECTION, BUT WAS REPORTEDLY NOT IMPLANTED IN THE SAME POCKET AREA. THE INFECTION HAS REPORTEDLY RESOLVED. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD CONFIRMED STERILIZATION OF DEVICES. INVESTIGATION TO DATE HAS BEEN UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 2747

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R MODEL 300-30 NCP BIPOLAR LEAD, EXPIR DATE 06/2003,| DATE OF MFG 07/2001, STERLIZATION LOT NO 3446