Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation

The implanted CRM device will have shock therapy and rate sensor temporarily deactivated or
placed in magnet mode during the time the IMED-4 is activated. The IMED-4 will be activated
for a time not to exceed 15 minutes. During the time the IMED-4 is active, the CRM device
programmer will print the voltage sensing of the implanted lead in real-time. The printout
will be examined for the presence of far-field sensing artifacts.

Inclusion Criteria:

- Subjects with an active implantable CRM device

- Subjects > 18 years of age

- Subjects who are ambulatory not requiring assistance for ambulation

- Subjects who have been informed of the nature of the study and agree to its
provisions and have provided written informed consent as approved by the IRB

Exclusion Criteria:

- Subjects who are pregnant or lactating or who have been pregnant within the past
three months

- Subjects who have tattoos on the back in the electrode patch placement region

- Subjects who have had a past allergic reaction to adhesives

- Subjects who have poor general physical/mental health that, in the opinion of the
investigator, will not allow the subject to be a good study candidate (i.e. other
disease processes, mental capacity, substance abuse, shortened life expectance, etc.)