Use Instructions

As a general guideline, patients implanted with an OPTIMIZER Smart Mini IPG who would like to

use a mobile phone are advised to hold the phone to the ear that is contralateral to the implant

site. Patients should not carry the phone in a breast pocket or on a belt closer than 10 in from the

implanted IPG because some phones emit signals even when they are turned on but not in use.

Compared to smaller cell phones, portable (handbag) and mobile (permanent car or boat

installation) phones will generally transmit at higher power levels. For phones with higher

transmission power levels, it is recommended to maintain a minimum separation of 20 in between

the antenna and the implanted IPG.

7.0 POTENTIAL ADVERSE EFFECTS

Examples of adverse effects that may occur as the result of the surgical procedure are listed below in the

order of their clinical severity:

1. Death

2. Arrhythmias (brady or tachyarrhythmias including fibrillation)

3. Stroke or TIA (“transient ischemic attack”)

4. Formation of blood clots

5. Respiratory/ventilatory failure

6. RA/RV perforation

7. Hemorrhage

8. Infection

9. Pleura or pericardial effusion

10. Pneumothorax

11. Injury to the heart or blood vessels

12. Damage to the heart muscle

13. Damage to the tricuspid valve, potentially resulting in tricuspid valve regurgitation

14. Damage to specialized tissue in the heart responsible for initiating each heart beat (i.e., the

heart’s conduction system)

15. Pain at the incision site

Examples of additional adverse effects potentially occurring secondary to CCM therapy delivery are listed

below in the order of their clinical severity:

1. Abnormal cardiac function

2. Atrial and ventricular tachyarrhythmias

3. Atrial and ventricular bradyarrhythmias

4. Worsening heart failure

5. Myocardial tissue damage

6. Lead dislodgement

7. Chest pain

8. Chest wall sensations

9. Inappropriate ICD behavior as a result of interaction with an implanted OPTIMIZER Smart Mini

IPG