PRECAUTIONS
Physicians should inform patients about all potential risks and adverse events
discussed in the NCP System physician’s manuals.
! Laryngeal irritation may result from stimulation. Patients who smoke may
have an increased risk of laryngeal irritation.
! Dyspnea may result from stimulation. Patients with chronic obstructive
pulmonary disease may have an increased risk of dyspnea.
! It is important to follow recommended implantation procedures and
intraoperative product testing described in this manual. During the
intraoperative Lead Test, infrequent incidents of bradycardia and/or asystole have occurred. If asystole, severe bradycardia (heart rate < 40 bpm), or a clinically significant change in heart rate is encountered during a Lead Test or during initiation of stimulation, physicians should be prepared to follow guidelines consistent with Advanced Cardiac Life Support (ACLS). Additionally, postoperative bradycardia can occur among patients with certain underlying cardiac arrhythmias. If a patient has experienced asystole, severe bradycardia (heart rate < 40 bpm) or a clinically significant change in heart rate during a Lead Test at the time of initial device implantation, the patient should be placed on a cardiac monitor during initiation of stimulation.
The safety of this therapy has not been systematically established for patients experiencing bradycardia or asystole during VNS Therapy System
implantation.
! Reversal of lead polarity has been associated with an increased chance of
bradycardia in animal studies. It is important to make sure that the Lead
connector pins are correctly inserted (white marker to + connection) into the Pulse Generator header.
! Do not program the NCP System to an ON or periodic stimulation
treatment for at least 14 days after the initial or replacement
implantation. Failure to observe this precaution may result in patient
discomfort or adverse events.
! Resetting the Pulse Generator turns the device OFF (output current = 0
mA), and all device history information is lost. The device history information should be printed out before resetting.
! It is important to follow infection control procedures. Infections related to
any implanted device are difficult to treat and may require that the device be explanted.
WARNINGS
Physicians should inform patients about all potential risks and adverse events discussed in the NCP System physician’s manuals.
! The safety and efficacy of the NCP System has not been established for uses not covered in the “Intended Use/ Indications” section of this manual.
! The safety and efficacy of the NCP System treatment have not been
established for stimulation of the right vagus nerve or of any other nerve,
muscle, or tissue.
! Excessive stimulation at a combination of high frequency (≥ 50 Hz) and an
excess duty cycle (that is, one that occurs when ON time is greater than OFF
time) has resulted in degenerative nerve damage in laboratory animals. An
excess duty cycle can be produced by continuous or frequent magnet
activation (> 8 hours), as determined by animal studies. Cyberonics
recommends against stimulation at these combinations of ranges.
! Aspiration may result from the increased swallowing difficulties reported by some patients during stimulation. Patients who have pre-existing swallowing difficulties are at greater risk for aspiration.
! Device malfunction could cause painful stimulation or direct current
stimulation. Either event could cause nerve damage and other associated
problems. Patients should be instructed to use the magnet to stop stimulation
if they suspect a malfunction, and then to contact their physician immediately for further evaluation. Prompt surgical intervention may be required if a malfunction occurs.
! Susceptible patients with predisposed cardiac conduction systems (re-entry pathway) have not been studied as part of controlled clinical trials to establish the safety of NCP system treatment in these patients. Evaluation by a cardiologist is recommended if the family history, patient history, or
electrocardiogram suggests an abnormal cardiac conduction pathway. Serum
electrolytes, magnesium, and calcium should be documented before
implantation. Post-implant electrocardiograms and Holter monitoring are
recommended if clinically indicated.
! Sudden unexplained death in epilepsy (SUDEP): Through August
1996, 10 sudden and unexplained deaths (definite, probable, and
possible) were recorded among the 1,000 patients implanted and treated
with the NCP device. During this period, these patients had accumulated
2,017 patient-years of exposure.