BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 730323 · Received June 21, 2006

    Report

    Report Number
    1644487-2006-00233
    Event Type
    Malfunction
    Date Received
    June 21, 2006
    Report Date
    May 25, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H.6 CODE 200: THE VNS THERAPY SYSTEM IS INDICATED FOR USE AS AN ADJUCTIVE THERAPY IN REDUCING THE FREQUENCY OF SEIZURES IN ADULTS AND ADOLESCENTS OVER 12 YEARS OF AGE WITH PARTIAL ONSET SEIZURES THA TARE REFRACTORY TO ANTIEPILEPTIC MEDICATIONS. IN THE UNITED STATES, THE VNS THERAPY SYSTEM IS APPROVED FOR USE IN ADULTS AND ADOLESCENTS OVER 12 YEARS OF AGE WITH PARTIAL ONSET SEIZURES THAT ARE REFRACTORY TO ANTIEPILEPTIC MEDICATIONS. CYBERONICS, INC, SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, CYBERONICS, OR CYBERONICS' EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR "MALFUNCTIONS". THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND CYBERONICS OBJECTS TO THEIR USE.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DEVICE DIAGNOSTIC TESTING (SYSTEMS DISGNOSTIC TEST) AT OFFICE VISIT RESULTED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT), INDICATING POSSIBLE LEAD MALFUNCTION. THE EVECTIVE REPLACEMENT INDICATOR WAS NO, RULING OUT GENERATOR BATTERY END OF LIFE AS A LIKELY CAUSE OF THE HIGH LEAD IMPEDANCE TEST RESULT. REVIEW OF X-RAYS BY TREATING PHYSICIAN DID NOT REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. TREATING PHYSICIAN HAS RECENTLY BEGUN SEEING THE PATIENT AND WAS THEREFORE NOT AWARE OF ANY RECENT INJURY OFR TRAUMA EXPERIENCED BY THE PATIENT THAT MAY HAVE DAMAGED THE NCP SYSTEM. REVISION SURGERY IS PLANNED DUE TO SUSPECTED LEAD DISCONTINUITY. NO SERIOUS INJURY WAS REPORTED IN CONJUNCTION WITH THE HIGH LEAD IMPEDANCE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ LYJ CYBERONICS, INC. 300-20 29947C

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR IMPLANT DATE| PULSE GEN MODEL 101, S/N 01497