No particular paddle placement can avoid such damage. To decrease the risk, it is
recommended to position the paddles as far away from the OPTIMIZER Smart IPG as
possible. In addition, paddle positions that would bring the OPTIMIZER Smart IPG into
the direct path of the defibrillation current should be avoided.
After defibrillation, the function of the OPTIMIZER Smart IPG should be closely
monitored. In the unlikely event of abnormal function, lead repositioning (or
replacement), reprogramming of the IPG may be required. If the device is found to have
reverted to its “DOWN” mode, it needs to be reset (how to proceed with an OPTIMIZER
Smart IPG reset is detailed in Section 21).
Internal defibrillation will not damage the device.
5.6 Radiation Therapy
Warning: Therapeutic equipment generating ionizing radiation, such as linear
accelerators and cobalt machines employed for treating malignant diseases,
can damage the circuits used in most active implantable devices. Because the
effect is cumulative, both dose rate and total dose determine if damage will
occur and its possible extent. Please be aware of the fact that certain types of
damage may not be immediately obvious. In addition, the electromagnetic
fields generated by some types of radiation equipment for beam “steering”
purposes can affect the function of the OPTIMIZER Smart IPG.
Radiation therapy can lead to a wide spectrum of effects, reaching from transient
interference to permanent damage. It is therefore advisable to locally shield the
OPTIMIZER Smart IPG against radiation if radiation therapy is to be used. During a
radiation treatment and thereafter, the function of the IPG needs to be monitored. If tissue
in the vicinity of the implant has to be irradiated, it may be advisable to relocate the IPG.
5.7 Nuclear Magnetic Resonance (NMR), Magnetic Resonance
Imaging (MRI)
The powerful magnetic fields and electromagnetic signals used with magnetic resonance
techniques can cause the OPTIMIZER Smart IPG to inhibit CCM signal delivery or to
revert to its “DOWN” mode [Standby (OOO) mode, with no delivery of CCM] with the
possible loss of statistical data. There is also a risk of device heating or migration as well
as the induction of dangerous currents in the implanted leads. Although unlikely, the
circuitry could also be damaged. To be on the safe side, patients with an implanted
OPTIMIZER Smart IPG should not be exposed to magnetic resonance devices. If
magnetic resonance methods have to be used, one can lower the risk of adverse events by
programming the OPTIMIZER Smart IPG into Standby (OOO) mode. The patient’s
peripheral pulse should be monitored while the magnetic resonance method is in
progress. Immediately thereafter, the OPTIMIZER Smart IPG should be checked for
proper function. If the device is found to have reverted to its “DOWN” mode, it needs to
be reset (how to proceed with an OPTIMIZER Smart IPG reset is detailed in Section 21).
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