BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 418283 · Received September 20, 2002

    Report

    Report Number
    1644487-2002-00399
    Event Type
    Injury
    Date Received
    September 20, 2002
    Date of Event
    May 1, 2001
    Report Date
    August 21, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED DEVICE TRACKING INFORMATION INDICATING THAT PATIENT HAD BEEN RE-IMPLANTED AFTER ONLY ONE YEAR AND ONE MONTH. IN THE PROCESS OF VERIFYING THE REASON FOR EXPLANT OF ORIGINAL NCP SYSTEM, IT WAS DISCOVERED THAT THE PATIENT'S ORIGINAL NCP SYSTEM WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 36902C

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| R 02/28/2002, DATE OF MFG 02/2000, STERILIZATION LOT| NO. 35576C.| MODEL 300-20 NCP BIPOLAR LEAD, EXPIRE DATE: