BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 513752 · Received January 21, 2004

    Report

    Report Number
    1644487-2004-00072
    Event Type
    Malfunction
    Date Received
    January 21, 2004
    Date of Event
    December 4, 2003
    Report Date
    December 15, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PT COULD NO LONGER FEEL STIMULATION. X-RAYS REVIEWED BY TREATING NEUROLOGIST DID NOT REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. FURTHER FOLLOW-UP REVEALED THAT TREATING NEUROLOGIST SUSPECTS CURRENT LEAKAGE AND HAS PROGRAMMED THE GENERATOR TO OFF. THE PT IS SCHEDULED FOR NCP SYSTEM EXPLANT (BOTH GENERATOR AND LEAD) AND WILL NOT BE RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 1202

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR 10/31/2002, DATE OF MFG 10/28/2000, STERILIZATION| LOT NO. 1258.| MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE