BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 492314 · Received October 24, 2003

    Report

    Report Number
    1644487-2003-00676
    Event Type
    Malfunction
    Date Received
    October 24, 2003
    Report Date
    September 25, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE PT'S SEIZURE HAVE IMPROVED SINCE NCP SYSTEM REPLACEMENT. PRODUCT ANALYSIS SUMMARY: THE LEAD ASSEMBLY WAS RETUNED FOR ANALYSIS IN ONE PIECE. THE LEAD WAS RECEIVED WITHOUT THE ELECTRODES. VISUAL ANALYSIS OF THE NEGATIVE COIL FOUND LEAK BREAK 10MM FROM THE CUT END. SCANNING ELECTRON MICROSCOPY WAS PERFORMED. SCANNING ELECTRON MICROSCOPY IDENTIFIED THAT THE LEAD BREAK MAY HAVE BEEN CAUSED BY A STRESS INDUCED FRACTURE. CONTINUITY CHECK USING A MULTIMETER WAS PERFORMED. CONTINUITY CHECK IDENTIFIED THAT THE NEGATIVE COIL MEASURED AS AN OPEN (INFINITE RESISTANCE). THIS IS AN INDICATION OF A LEAD BREAK. OTHER CONDITIONS OF THE LEAD ARE CONSISTED WITH CONDITIONS THAT EXIST AFTER THE EXPLANT PROCEDURE. THE CONCOMITANT DEVICE (PULSE GENERATOR) WAS ALSO RETURNED AND ANALYZED. THE PULS GENERATOR MET ELECTRICAL TEST SPECIFICATIONS. EXTERNA VISUAL INSPECTION OF THE GENERATOR REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT RESULTED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT), INDICATIING POSSIBLE DEVICE MALFUNCTION. THE ELECTIVE REPLACEMENT INDICATOR WAS NO, INDICATING THAT THE GENERATOR HAD NOT REACHED END OF SERVICE. THE PATIENT HAD REPORTEDLY BEGUN TO EXPERIENCE A DECREASE IN SEIZURE CONTROL. THE PATIENT'S DECREASE IN SEIZURE CONTROL WAS NOT ABOVE THEIR PRE-VNS BASELINE FREQUENCY, BUT WAS A DECREASE FROM THE CONTROL THAT THEY HAD PREVIOUSLY EXPERIENCED WITH THE VNS THERAPY. THE PATIENT IS NOT ABLE TO VERBALIZE WHETHER OR NOT THEY STILL FEEL STIMULATION. TREATING NEUROLOGIST IS UNAWARE OF WHETHER THE PATIENT HAS SUFFERED ANY RECENT INJURY OR TRAUMA THAT MAY HAVE DAMAGED THE NCP SYSTEM. THE PATIENT HAS NOT ATTENDED THEIR LAST TWO SCHEDULE APPOINTMENTS FOR FURTHER DEVICE DIAGNOSTIC TESTING. INVESTIGATION TO DATE HAS BEEN UNABLE TO DETERMINE WHETHER THE NCP SYSTEM HAS MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 4039

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR DATE OF MFG 10/10/2001, STERILIZATION LOT NO. 4309| MODEL 101 NCP PULSE GENERATOR, EXPIR 11/30/2002,