BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 375797 · Received February 1, 2002

    Report

    Report Number
    1644487-2002-00034
    Event Type
    Malfunction
    Date Received
    February 1, 2002
    Date of Event
    January 1, 2001
    Report Date
    January 2, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT BOTH LEAD TEST AND NORMAL MODE DIAGNOSTIC TEST OF PATIENT'S DEVICE IN 2002 RESULTED IN HIGH LEAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT). ERI (ELECTIVE REPLACEMENT INDICATOR) FLAG WAS NO, INDICATING THAT THE GENERATOR WAS NOT NEARING END OF SERVICE. PATIENT WAS LAST SEEN TWO DAYS LATER AT WHICH TIME THE LEAD IMPEDANCE READINGS WERE OK. X-RAY TWO DAYS BEFORE WAS REVIEWED BY PHYSICIAN AND INDICATED A BREAK IN THE LEAD COIL. DEVICE WAS PROGRAMMED TO OFF THAT DAY AND MEDICATIONS WERE ADDED TO THE PATIENT'S DRUG REGIMEN. IT WAS REPORTED THAT THE PATIENT HAS NOT EXPERIENCED A DECREASE IN SEIZURE CONTROL. THERE ARE NO PLANS TO EXPLANT THE DEVICE THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 28125C

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR MODEL 100 NCP PULSE GENERATOR, EXPIRE DATE| 03/31/2001, MFG DATE 10/1999 STERILE LOT NO 29559C