BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 361277 · Received November 9, 2001

    Report

    Report Number
    1644487-2001-00598
    Event Type
    Malfunction
    Date Received
    November 9, 2001
    Date of Event
    October 10, 2001
    Report Date
    October 10, 2001
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT HIGH LEAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT) WAS OBTAINED DURING LEAD TEST AT FOLLOW-UP VISIT. X-RAY WAS ORDERED AND PHYSICIAN NOTICED A BREAK IN THE LEAD. NCP SYSTEM WAS EXPLANTED AND PATIENT WAS REIMPLANTED WITH A NEW NCP SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50155 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 23852C

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR MODEL 100 NCP PULSE GENERATOR.