BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 579787 · Received February 21, 2005

    Report

    Report Number
    1644487-2005-00090
    Event Type
    Malfunction
    Date Received
    February 21, 2005
    Report Date
    January 25, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT RESULTED IN HIGH LEAD IMPEDANCE READING (DO-DC CODE 7), INDICATING POSSIBLE DEVICE MALFUNCTION. NO ADVERSE EVENT WAS REPORTED IN CONJUNCTION WITH THE HIGH LEAD IMPEDANCE CONDITION. THE PATIENT HAD NOT SUFFERED ANY RECENT INJURY OR TRAUMA THAT MAY HAVE DAMAGED THE NCP SYSTEM. REVIEW OF X-RAYS BY TREATING NEUROLOGIST DID NO REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY AFFECT DEVICE PERFORMANCE. LEAD BREAK IS SUSPECTED. THE PATIENT HAS BEEN REFERRED ROR NEUROSURGICAL CONSULT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 16551C

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR MODEL 100 NCP PULSE GENERATOR: IMPLANTED| MODEL 101 NCP PULSE GENERATOR: EXPLANTED| MODEL 101 NCP PULSE GENERATOR: IMPLANTED| STERILIZATION LOT #8719 DATE OF MFG| MODEL 100 NCP PULSE GENERATOR: EXPLANTED| MODEL 101 NCP PULSE GENERATOR, EXPIR DATE