BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 404063 · Received July 3, 2002

    Report

    Report Number
    1644487-2002-00288
    Event Type
    Malfunction
    Date Received
    July 3, 2002
    Date of Event
    May 1, 2002
    Report Date
    June 6, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT LEAD TEST AT OFFICE VISIT ON 06/2002 RESULTED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT), INDICATING POSSIBLE DEVICE MALFUNCTION. PHYSICIAN'S RECORDS INDICATE THAT DEVICE DIAGNOSTIC TESTING DURING IMPLANT SURGERY RESULTED IN NORMAL READINGS, INDICATING PROPER DEVICE FUNCTION AT THAT TIME. THE PATIENT IS REPORTEDLY NOT PHYSICALLY ACTIVE AND HAD NOT SUFFERED ANY TRAUMA THAT MAY HAVE DAMAGED THE NCP SYSTEM. REVIEW OF X-RAYS DID NOT REVEAL ANY ANOMALIES OR DISCONTINUITIES IN THE NCP SYSTEM. THE PATIENT'S NCP SYSTEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 4137

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR MODEL 101 NCP PULSE GENERATOR, EXPIRE DATE| LOT NO. 5692.| 9/30/2003, DATE OF MFG. 4/9/2002, STERILIZATION