User's Manual

20 Cardiac Airbag Technical Manual
1.7 Patient Selection and Treatment
1.7.1 Individualization of Treatment
• Determine whether the expected device benefits
outweigh the possibility of early device replacement for
patients whose ventricular tachyarrhythmias require
frequent shocks.
• Determine if the device and programmable options are
appropriate for patients with drug-resistant
supraventricular tachyarrhythmias (SVTs), because
drug-resistant SVTs can initiate unwanted device
therapy.
• Direct any questions regarding individualization of
patient therapy to your BIOTRONIK representative or
BIOTRONIK technical services at 1-800-547-0394.
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 (72%) of the patients receiving an ICD
in the Phylax XM clinical study 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 electrical wheel chair or
other electrical (external or implanted devices).
1.8 Patient Counseling Information
The pulse generator is 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.