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2 General Safety Instructions
General Safety Instructions2365353-ATechnical manual for the implan tEvia DR-T, DR, SR-T, SR
Possible Medical Complications
General information
on medical complications
Complications for patients and implant systems generally recognized among prac-
titioners also apply to BIOTRONIK implants.
• Normal complications may include fluid accumulation within the implant
pocket, infections, or tissue reactions. Primary sources of complication infor-
mation include current scientific and technological knowledge.
• It is impossible to guarantee the efficacy of antitachycardia therapy, even if the
programs have proven successful during tests or subsequent electrophysiolog-
ical examinations. In rare cases the set parameters may become ineffective. In
particular it cannot be excluded that tachyarrhythmias be induced.
Skeletal myopotentials Bipolar sensing and control of sensitivity are adapted by the implant to the rate
spectrum of intrinsic events so that skeletal myopotentials are usually not sensed.
Skeletal myopotentials can nonetheless be sensed as intrinsic events especially
with a unipolar configuration and, depending on the interference pattern, may
cause inhibition or antiarrhythmia therapy.
Nerve and
muscle stimulation
An implant system consisting of a unipolar lead and an uncoated implant may
result in undesirable pacing of the diaphragm in the case of an initial or permanent
high setting of the pacing amplitude.
• BIOTRONIK also provides coated implants.
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