BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 452998 · Received April 4, 2003

    Report

    Report Number
    1644487-2003-00147
    Event Type
    Malfunction
    Date Received
    April 4, 2003
    Date of Event
    March 1, 2003
    Report Date
    March 5, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT IN 2003 RESULTED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT), INDICATING POSSIBLE DEVICE MALFUNCTION. IT WAS REPORTED THAT THE PATIENT HAD RECENTLY EXPERIENCED AN INCREASE IN SEIZURES; HOWEVER, THERE WAS NO SERIOUS INJURY REPORTED DUE TO THE REPORTED SEIZURE INCREASE. X-RAYS REVEALED A BREAK IN THE LEAD COIL. THE PATIENT IS SCHEDULED FOR NCP SYSTEM REPLACEMENT SURGERY IN 04/2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 1670

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR