BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 612175 · Received September 24, 2004

    Report

    Report Number
    1644487-2004-00842
    Event Type
    Malfunction
    Date Received
    September 24, 2004
    Date of Event
    January 1, 2004
    Report Date
    August 25, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FURTHER FOLLLOW-UP REVEALED THAT THE PT UNDERWENT NCP SYSTEM REPLACEMENT. BOTH THE PULSE GENERATOR AND BIPOLAR LEAD WERE REPLACED.

    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), INDICATING POSSIBLE DEVICE MALFUNCTION. THE ELECTIVE REPLACEMENT INDICATOR WAS NO, INDICATING THAT THE GENERATOR HAD NOT REACHED END OF SERVICE. DEVICE DIAGNOSTIC TESTING AT PREVIOUS OFFICE VISIT 6 MONTHS PRIOR WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION AT THAT TIME. THE PATIENT HAD NOT SUFFERED ANY RECENT INJURY OR TRAUMA THAT MAY HAVE DAMAGED THE NCP SYSTEM. NO ADVERSE EVENT WAS REPORTED IN CONJUNCTION WITH THE HIGH LEAD IMPEDANCE CONDITION. REVIEW OF X-RAYS BY RADIOLOGIST DID NOT REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. REVIEW OF X-RAYS BY DEVICE MANUFACTURER REVEALED A GROSS FRACTURE IN THE LEAD WIRE, APPROXIMATELY 5CM FROM THE CLAVICLE TOWARD THE PATIENT'S HEAD. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY AFFECT DEVICE PERFORMANCE. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT WANTS TO HAVE THE NCP SYSTEM REPLACED; HOWEVER, INSURANCE CARRIER REIMBURSEMENT IS INSUFFICIENT. THE PATIENT'S FAMILY PLANS TO WAIT UNTIL THE PATIENT IS OLD ENOUGH BEFORE HAVING THE NCP SYSTEM REPLACED. NEUROLOGIST PLANS TO LEAVE THE PATIENT'S DEVICE IMPLANTED AS THE PATIENT'S SEIZURES ARE WELL CONTROLLED. REVISION SURGERY WILL BE RECONSIDERED IF THE PATIENT EXPERIENCES AN INCREASE IN SEIZURES.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS FOR THE LEAD WAS COMPLETED. PRODUCT ANALYSIS SUMMARY: THE ENTIRE LEAD WAS NOT RETURNED FOR ANALYSIS; APPROXIMATELY 35CM WAS RECEIVED. A CONTINUITY CHECK WAS PERFORMED AND NO DISCONTINUITIES WERE IDENTIFIED. THE CONDITION OF THE LEAD, IN GENERAL, IS CONSISTEMT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. THE LEAD PIN SHOWED EVIDENCE OF A PROPER MECHANICAL AND ELECTRICAL CONNECTION. THE RETURNED PORTION OF THE LEAD DID NOT SHOW ANY ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED HIGH IMPEDANCE. THE CONCOMITANT (PULSE GENERATOR) DEVICE WAS ALSO RETURNED AND ANALYZED. THE PULSE GENERATOR IS OPERATING WITHIN THE MFR'S FINAL ELECTRICAL TEST SPECIFICATION. THE PULSE GENERATOR DID NOT S HOW ANY CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENTS IS UNK. THE ENTIRE LEAD WAS NOT RETURNED FOR ANALYSIS, THEREFORE, IT IS POSSIBLE THAT THE PROBLEM MAY HAVE OCCURRED WITH THE PORTION OF THE LEAD THAT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 4678

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR