BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 651362 · Received December 1, 2005

    Report

    Report Number
    1644487-2005-00830
    Event Type
    Malfunction
    Date Received
    December 1, 2005
    Date of Event
    January 1, 2005
    Report Date
    November 1, 2005
    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

    PT UNDERWENT NCP SYSTEM REPLACEMENT SURGERY DUE TO HIGH LEAD IMPEDANCE TEST RESULT (DC-DC CODE 7 AND LIMIT), INDICATING POSSIBLE DEVICE MALFUNCTION. IT WAS REPORTED THAT THE PT'S NCP SYSTEM WAS "DYSFUNCTIONAL DUE TO MOTOR VEHICLE ACCIDENT". IT WAS ALSO REPORTED THAT DURING THE REPLACEMENT SURGERY, SIGNIFICANT SCARRING AT BOTH THE ELECTRODE AND CONNECTOR PIN SITES WAS NOTED, POSSIBLY AFFECTING THE CONDUCTION OF THE DEVICE STIMULATION CURRENT. BOTH THE LEAD AND GENERATOR WERE REPLACED. THE USER FACILITY REPORT INDICATES THAT THE PT'S NCP SYSTEM WAS REPLACED DUE TO A BROKEN WIRE. THE PT'S INVOLVEMENT IN A MOTOR VEHICLE ACCIDENT IS THE LIKELY CAUSE OF THE REPORTED LEAD FRACTURE. THE USER FACILITY HAS INDICATED THAT THE EXPLANTED PRODUCTS WILL NOT BE RETURNED TO MFR FOR ANALYSIS AS DETERMINED BY THE FACILITY RISK MGR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD (LYJ) LYJ CYBERONICS, INC. 300-30 5760

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR