User Manual

68 Lumax Technical Manual
If the patient is being treated with antiarrhythmic or cardiac drugs,
the patient should be on a maintenance drug dose rather than a
loading dose at the time of pulse generator implantation. If
changes to drug therapy are made, repeated arrhythmia
inductions are recommended to verify pulse generator detection
and conversion. The pulse generator also may need to be
reprogrammed.
Changes in a patient’s antiarrhythmic drug or any other
medication that affect the patient’s normal cardiac rate or
conduction can affect the rate of tachyarrhythmias and/or efficacy
of therapy.
If another cardiac surgical procedure is performed prior to
implanting the pulse generator, it may be preferable to implant the
lead system at that time. This may prevent the need for an
additional thoracic operation.
1.7.2 Specific Patient Populations
Pregnancy - If there is a need to image the device, care should
be taken to minimize radiation exposure to the fetus and the
mother.
Nursing Mothers - Although appropriate biocompatibility testing
has been conducted for this implant device, there has been no
quantitative assessment of the presence of leachables in breast
milk.
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.