BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 58 / 176

50 Lumax Technical Manual
Geriatric Patients - Most (about 71%) of the patients receiving a
CRT-D or ICD in the clinical studies detailed in this manual were
over the age of 60 years (see Clinical Studies).
Handicapped and Disabled Patients - Special care is needed in
using this device for patients using an electrical wheel chair or
other electrical (external or implanted) devices.
1.8 Patient Counseling Information
The implanted devices are subject to random component failure.
Such failure could cause inappropriate shocks, induction of
arrhythmias or inability to sense arrhythmias, and could lead to
the patient’s death.
Persons administering CPR may experience the presence of
voltage on the patient’s body surface (tingling) when the patient’s
CRT-D/ICD system delivers a shock.
A patient manual is available for the patient, patient’s relatives,
and other interested people. Discuss the information in the
manual with concerned individuals both before and after pulse
generator implantation so they are fully familiar with operation of
the device. (For additional copies of the patient manual, contact
the BIOTRONIK at the address listed in this manual.)
1.9 Evaluating Prospective CRT-D/ICD
Patients
The prospective ICD/CRT-D implant candidate should undergo a
cardiac evaluation to classify any and all tachyarrhythmias. In
addition, other patient specific cardiac information will help in
selecting the optimal device settings. This evaluation may
include, but is not limited to:
•
an evaluation of the specific tachycardia rate(s)
•
the confirmation and/or evaluation of any supraventricular
arrhythmias or bradyarrhythmias
•
the evaluation of various ATP and cardioversion
therapies
•
the presence of any post-shock arrhythmias, and