BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 402981 · Received June 28, 2002

    Report

    Report Number
    1644487-2002-00245
    Event Type
    Malfunction
    Date Received
    June 28, 2002
    Date of Event
    May 1, 2002
    Report Date
    May 28, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PATIENT'S LEAD WAS REPLACED DUE TO SUSPECTED LEAD DISCONTINUITY. NO ADVERSE EVENT WAS REPORTED. FURTHER FOLLOW-UP REVEALED THAT IT WAS FIRST SUSPECTED SOMETHING WAS WRONG WITH THE LEAD DURING A FOLLOW UP VISIT ON 05/08/2002. DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT ON 05/08/2002 RESULTED IN NORMAL MODE HIGH LEAD INPEDANCE READING (DC-DC CODE 7 AND HIGH) AND LEAD TEST HIGH IMPEDANCE READING (DC-DC CODE 5 AND HIGH), INDICATING POSSIBLE DEVICE MALFUNCTION. THE VISIT PRIOR TO THIS APPOINTMENT WAS ON 02/06/2002. DURING THE 02/06/2002 VISIT, DEVICE DIAGNOSTIC TESTING WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION AT THAT TIME. IT WAS ALSO REPORTED THAT X-RAYS WERE TAKEN ON 05/08/2002 AND NO BREAK IN THE LEAD WAS OBSERVED. IT WAS REPORTED THAT DURING LEAD REPLACEMENT SURGERY IN 2002, A BREAK IN THE LEAD WAS NOTED UPON VISUAL INSPECTION. THE PATIENT'S GENERATOR WAS PROGRAMMED TO ON AFTER SURGERY TO 0.25MA OUTPUT CURRENT. THE PATIENT HAS SINCE BEEN SEEN BY PHYSICIAN AND DEVICE OUTPUT CURRENT INCREASED TO PRE-SURGERY SETTING OF 2.25MA OUTPUT CURRENT WHICH PATIENT TOLERATED WELL. IT WAS REPORTED THAT IT IS NOT BELIEVED THAT THE PATIENT SUFFERED ANY INJURY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE LEAD BREAK, ALTHOUGH, THE PATIENT DOES SUFFER FROM DROP SEIZURES. THE PATIENT HAS BENEFITED FROM VNS THERAPY. THEIR SEIZURES ARE NOT AS SEVERE AND THE PATIENT IS MORE ALERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 23529C

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR EXPLANTED 2001. MODEL 101 NCP PULSE GENERATOR,| 10/20/2001, STERILIZATION LOT NO. 4223.| INPLANTED 2001, EXPIR DATE 03/31/2003, DATE OF MFG| MODEL 100 NCP PULSE GENERATOR, INPLANTED 1999,