BEUDAMED
    FDA Adverse Event Other Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 591040 · Received June 3, 2004

    Report

    Report Number
    1644487-2004-00485
    Event Type
    Other
    Date Received
    June 3, 2004
    Date of Event
    May 4, 2004
    Report Date
    May 4, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE DEVICE DIAGNOSTIC TESTING RESULTED IN HIGH LEAD IMPEDANCE (DC-DC CODE 7 AND LIMIT), INDICATING POSSIBLE DEVICE MALFUNCTION. REPORTER ALSO INDICATED THET THE PT WAS SEEN IN THE HOSP EMERGENCY ROOM AFTER THEIR FRIEND HAD BEAT THEM UP. X-RAYS REVIEWED BY PHYSICIAN IDENTIFIED A COMPLETE BREAK IN THE LEAD. THE PT EXPERIENCED A SUDDEN INCREASE IN SEIZURES AND COULD NO LONGER FEEL STIMULATION. FURTHER FOLLOW-UP REVEALED THAT THE PT UNDERWENT NCP SYSTEM REPLACEMENT. DEVICE DIAGNOSTIC TESTING ON THE NEW SYSTEM WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 6055

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR LOT NO. 5919.| MODEL 101 NCP PULSE GENERATOR, EXPIR DATE| 10/31/2003, DATE OF MFG 04/30/2002, STERILIZATION