BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 611892 · Received July 28, 2004

    Report

    Report Number
    1644487-2004-00624
    Event Type
    Malfunction
    Date Received
    July 28, 2004
    Report Date
    July 1, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT RESULTED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT), INDICATING POSSIBLE DEVICE MALFUNCTION. PREVIOUS DEVICE DIAGNOSTIC TESTING APPROXIMATELY 10 MONTHS EARLIER WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION AT THAT TIME. IT WAS REPORTED THAT THE PT HAD NOT SUFFERED ANY RECENT INJURY OR TRAUMA THAT MAY HAVE DAMAGED THE NCP SYSTEM, BUT THAT THE PT USES A PULSATING AIR CHEST VEST TO GET SECRETIONS OUT OF THEIR LUNGS. THE VEST SENDS A PULSATING PRESSURE OF AIR CONTINUOUSLY OVER THE PT'S CHEST. REVIEW OF X-RAYS BY NEUROLOGIST DID NOT REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. THE PT UNDERWENT NCP SYSTEM REPLACEMENT SURGERY. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY EFFECT DEVICE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 4758

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR