Disclosure for Medtronic Pacing Systems
Medtronic pacemakers are indicated for rate adaptive pacing in patients
who may benefit from increased pacing rates concurrent with increases
in activity (Medtronic Kappa®, Sigma Series, and Thera®
(i-series)) and increases in activity and/or minute
ventilation (Medtronic Kappa 400 Series).
Medtronic pacemakers are also indicated for dual chamber and atrial
tracking modes in patients who may benefit from maintenance of AV
synchrony. Dual chamber modes are specifically indicated for treatment
of conduction disorders that require restoration of both rate and
AV synchrony, which include various degrees of AV block to maintain
the atrial contribution of cardiac output and VVI intolerance (e.g.,
pacemaker syndrome) in the presence of persistent sinus rhythm.
The Medtronic CareLink Programmer and the Medtronic 9790 Programmer
are intended for use by physicians to noninvasively program Medtronic
implantable devices. Specific applications are determined by the
software installed in the programmer at the time of its use.
9462 Cardiac Monitor
The Medtronic 9462 Remote Assistant Cardiac Monitor is intended
for use by the patient in combination with a Medtronic implantable
pacemaker with Remote Assistant capabilities.
Medtronic pacemakers are contraindicated for the following applications:
- Dual chamber atrial pacing in patients with chronic refractory
- Asynchronous pacing in the presence (or likelihood) of competitive
paced and intrinsic rhythms.
- Unipolar pacing for patients with an implanted cardioverter
defibrillator (ICD) because it may cause unwanted delivery or
inhibition of ICD therapy.
- Medtronic Kappa 400 Series pacemakers are contraindicated for
use with epicardial leads and with abdominal implantation.
Pacemaker patients should avoid sources of magnetic resonance imaging,
diathermy, high sources of radiation, electrosurgical cautery, external
defibrillation, lithotripsy, and radio frequency ablation to avoid
electrical reset of the device, inappropriate sensing and/or therapy.
9462 Cardiac Monitor
Operation of the Model 9462 Remote Assistant Cardiac Monitor
near sources of electromagnetic interference such as cellular phones,
computer monitors, etc., may adversely affect the performance of
See the appropriate technical manual for detailed information regarding
indications, contraindications, warnings, and precautions.
Caution: Federal law (U.S.A.) restricts this device to sale
by or on the order of a physician.