User's Manual

US-ENGLISH – 27
Antiarrhythmic drug therapy: 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 ICD
implantation. If changes to drug therapy are made, repeated arrhythmia
inductions are recommended to verify ICD detection and conversion.
The ICD also may need to be reprogrammed.
Changes in a patient’s antiarrhythmic drug or any other medication that
affects the patient’s normal cardiac rate or conduction can affect the
rate of tachyarrhythmias and/or efficacy of therapy.
Direct any questions regarding the individualization of patient therapy
to Sorin CRM’s representative.
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 foetus 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.
Pediatric Patients: This device has not been studied in patients
younger than 18 years of age.
Geriatric Patients: Most of the patients receiving this device in clinical
studies were over the age of 60 years.
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.