Medtronic D224DRG Addendum

CONSULTA® / SECURA™ /
CONCERTO® II / VIRTUOSO® II /
MAXIMO® II

Projected service life information related to remote
monitoring

Clinician Manual Supplement

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

The following are trademarks or registered trademarks of Medtronic in the United
States and possibly in other countries:

Concerto, Consulta, MVP, Maximo, Medtronic, Medtronic CareLink, Secura,
Virtuoso

Medtronic

CONSULTA® / SECURA™ / CONCERTO® II /

VIRTUOSO® II / MAXIMO® II

1 About this supplement

The Medtronic CareLink Monitor Model 2490C has been updated to allow greater flexibility
in scheduling automatic remote transmissions.

This supplement describes the effect of Medtronic CareLink Monitor remote transmissions
on device service life for the following Medtronic devices:

CRT-D devices DR ICD devices VR ICD devices

●

Consulta CRT-D

●

Concerto II CRT-D

●

Maximo II CRT-D

In each of the following sections, the projected service life estimates from the applicable
device manuals are included for reference. Each section also includes specific information
and examples describing the impact of remote transmissions on device service life.

●

Secura DR

●

Virtuoso II DR

●

Maximo II DR

●

Secura VR

●

Virtuoso II VR

●

Maximo II VR

Clinician Manual Supplement 3

Medtronic

CONSULTA® / SECURA™ / CONCERTO® II /

VIRTUOSO® II / MAXIMO® II

2 Projected service life information

2.1 Projected service life for CRT-D devices

The projected service life in years for the device is shown in Table 1. The data is based on
pacing outputs programmed to the specified amplitude and 0.4 ms pulse width, 100%
biventricular pacing, the specified percentage of atrial pacing at 60 bpm and the remainder
at 70 bpm atrial tracking.

The projected service life estimates assume the default automatic capacitor formation
setting. As a guideline, each full energy charge decreases projected service life by
approximately 25 days. The service life of the device is affected by the programmed settings
for certain features, such as Pre-arrhythmia EGM storage.

Projected service life estimates are based on accelerated battery discharge data and device
modeling as specified. These values should not be interpreted as precise numbers.

Table 1. Projected service life in years

500 Ω pac­ing impe­dance

2.5 Vc3.5 Vd2.5 Vc3.5 Vd2.5 Vc3.5 V

600 Ω pacing
impedance

900 Ω pacing
impedance

Percent pac­ing

DDD, 0%
0% Atrial
100% Biven­tricular

DDD, 15%
15% Atrial
100% Biven­tricular

DDD, 50%
50% Atrial
100% Biven­tricular

Maximum
energy
charging fre­quency

Semi-annual Off 5.8 4.5 6.0 4.8 6.5 5.5
Quarterly Off 5.3 4.2 5.5 4.5 5.9 5.0
Semi-annual On 5.7 4.4 5.9 4.7 6.4 5.4
Quarterly On 5.2 4.2 5.4 4.4 5.8 5.0

Semi-annual Off 5.7 4.5 6.0 4.8 6.5 5.4
Quarterly Off 5.3 4.2 5.5 4.4 5.9 5.0
Semi-annual On 5.6 4.4 5.9 4.7 6.3 5.3
Quarterly On 5.2 4.1 5.4 4.4 5.8 4.9

Semi-annual Off 5.6 4.3 5.9 4.6 6.4 5.3
Quarterly Off 5.2 4.0 5.4 4.3 5.8 4.9
Semi-annual On 5.5 4.2 5.8 4.5 6.3 5.2
Quarterly On 5.1 4.0 5.3 4.2 5.7 4.8

a

Pre-arrhyth­mia EGM stor-

b

age

d

4 Clinician Manual Supplement