BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIOPLAR LEAD

    MDR report key: 517489 · Received February 3, 2004

    Report

    Report Number
    1644487-2004-00094
    Event Type
    Malfunction
    Date Received
    February 3, 2004
    Date of Event
    September 2, 2003
    Report Date
    January 5, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PATIENT UNDERWENT NCP SYSTEM REPLACEMENT SURGERY DUE A JAW PAIN. THE PATIENT REPORTEDLY EXPERIENCED PAIN UP THE SIDE OF THEIR FACE WITH STIMULATION. DEVICE DIAGNOSTIC TESTING WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION. X-RAYS REVIEWED BY TREATING NEUROSURGEON DID NOT REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. THE LEAD WAS REPLACED DUE TO SUSPECTED MICROFRACTURE OF THE INSULATION. THE GENERATOR WAS REPLACED PROPHYLACTICALLY AS IT WOULD SOON BE NEARING END OF SERVICE. THE PATIENT'S PAIN RESOLVED FOLLOWING NCP SYSTEM REPLACEMENT SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR EXPIR DATE 08/31/2001, DATE OF MFG 03/06/2000,| STERILIZATION LOT NO. 36078C.| MODEL 101 NCP PULSE GENERATOR,