User's Manual

133
Cautionary Notes
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Cautionary Notes
The pacemaker, the lead(s), and, if used, the lead extensions and
adapters, become part of the artificial pacing system upon
implantation. The functioning of the artificial pacing system depends
on all these components, as well as the physiologic condition of the
patient.
The following notes are intended to emphasize some aspects that have
been deemed especially important in the medical literature for
evaluating and avoiding risks. This information could be useful in
evaluating and avoiding risks, but it is not a substitute for the study of
medical literature.
Medical Complications
Possible medical complications of cardiac pacemaker therapy include
the following: necrotic tissue formation, thrombosis, embolisms,
elevated pacing thresholds, foreign body rejection phenomena, cardiac
tamponade, muscle/nerve stimulation, infection, and pacemaker-
induced arrhythmias (some of which could be life-threatening, such as
ventricular fibrillation).
Technical Malfunctioning
Events that could compromise functioning are, for example: a defect in
one of the pacemaker components, battery depletion, lead dislocation,
lead fracture, or an insulation defect.
Muscle Potentials
The filter properties of BIOTRONIK pacemakers have been adjusted to
the rate spectrum of cardiac actions, so the risk of sensing skeletal
muscle potentials is low. However, this risk cannot be completely ruled
out, especially not in unipolar systems and at a high pacemaker
detection sensitivity. If the pacemaker senses skeletal myopotentials as
intrinsic cardiac activity, then inhibition or asynchronous and/or
triggered pacing may result, depending on the pacing mode and the
interference pattern. You can test the whether the pacing system
functioning is safe from skeletal myopotentials, for example, by
monitoring the Holter or pacemaker performance while the patient
does movements involving chest muscles.