BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 571363 · Received January 19, 2005

    Report

    Report Number
    1644487-2005-00062
    Event Type
    Malfunction
    Date Received
    January 19, 2005
    Date of Event
    January 1, 2004
    Report Date
    December 20, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT ANALYSIS SUMMARY: THE LEAD ASSEMBLY WAS RETURNED FOR ANALYSIS IN 10 PIECES. THE LEAD WAS RECEIVED WITH THE NEGATIVE ELECTRODE IN PIECES. VISUAL INSPECTION OF THE LEAD BODY PORTION IDENTIFIED FOUR ABRADED OPENINGS IN THE OUTER SILICONE TUBING. DRIED BODY FLUIDS WERE INTENSIFED INSIDE THE OUTER SILICONE TUBING OF THE OPENINGS. VISUAL INSPECTION OF THE COIL IDENTIFIED TWO LEAD BREAKS ON THE ENDS. SCANNING ELECTION MICROSCOPY WAS PERFORMED AT THE AREA WHERE THE LEAD BREAKS WERE IDENTIFIED. SCANNING ELECTRON MICRSOCOPY REVEALED THAT FATIGUE FRACTURES OCCURRED ON THE ENDS OF THE LEAD COILS. PITTING WAS IDENTIFIED ON ONE OF THE SURFACES OF THE LEAD COILS. THE PITTING INDICATES THAT STIMULATION WAS PRESENT FOR SOME PERIOD OF TIME AFTER THE FRACTURE OCCURRED. CONTINUITY CHECK USING A MULTIMETER WAS PERFORMED. CONTINUITY CHECK DID NOT IDENTIFY ANY OTHER DISCONTINUITIES ON THE PORTIONS OF THE LEAD RETURNED. OTHER CONDITIONS OF THE LEAD WERE CONSISTENT WITH CONDITIONS THAT EXIST FOLLOWING THE XPLANT PROCEDURE. THE CONCOMITANT DEVICE (PULSE GENERATOR) WAS ALSO RETURNED AND ANALYZED. THE PULSE GENERATOR MET ELECTRICAL TEST SPECIFICATIONS. EXTERNAL VISUAL INSPECTION OF THE GENERATOR REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    INDICATED THAT VNS PT UNDERWENT NCP SYSTEM REPLACEMENT SURGERY DUE TO DEVICE MALFUNCTION. LEAD BREAK WAS CONFIRMED VIA X-RAY PRIOR TO SURGERY AND PREVIOUS DEVICE DIAGNOSTIC TESTING REVEALED THAT THE PULSE GENERATOR WAS NO LONGER ABLE TO DELIVER THE STIMULATION AT THE PROGRAMMED LEVEL. DEVICE DIAGNOSTIC TESTING AT THE START OF NCP SYSTEM REPLACEMENT SURGERY RESULTED IN A LEAD TEST READING OF DC-DC CODE 7 AND LIMIT, INDICATIVE OF AN NCP SYSTEM DISCONTINUITY. IT WAS REPORTED THAT THE PT "PLAYS WITH DEVICE" THROUGH THE SKIN. THE PT WAS REPORTEDLY EXPERIENCING AN INCREASE IN SEIZURE ACTIVITY BUT DENIED ANY RECENT INJURY OR TRAUMA THAT MAY HAVE DAMAGED THE NCP SYSTEM. DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT APPROXIMATELY 3 MONTHS PRIOR TO NCP SYSTEM REPLACEMENT SURGERY WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION AT THAT TIME. THE LEAD TEST RESULT IN DC-DC CODE 6 AND OUTPUT STATUS OK, INDICATING THAT THE GENERATOR WAS WORKING HARDER TO DELIVER THE PROGRAMMED THERAPY BUT NOT SUGGESTIVE OF A DISCONTINUITY IN THE NCP SYSTEM. THE NORMAL MODE TEST RESULTED IN DC-DC CODE 7 AND OUTPUT STATUS LIMIT, INDICATING THAT THE PT WAS STILL RECEIVING THERAPY BUT THAT THE GENERATOR WAS NO LONGER ABLE TO DELIVER STIMULATION AT THE PROGRAMMED LEVEL OF OUTPUT CURRENT. 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 33300C

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR STERILIZATION LOT NO. 36236C| EXPIR DATE 08/31/2001, DATE OF MFG 03/08/2000,| MODEL 101 NCP PULSE GENERATOR