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implant location may prevent communication between the Remote Controller and the implanted
Microstimulator, and therapy may not be possible. If the distance between the devices is greater than
2.5cm, the Remote Controller may not be able to communicate with the Microstimulator. If it is difficult
to establish communication with the Microstimulator, re-evaluate the implant depth specified in the
Programming Software.
Lead Tip Migration
The Microstimulator Lead may migrate from its initial implant location. Lead migration may result in
changes in SPG Microstimulator System effectiveness and the need for additional surgical
procedures. To help minimize the chance of lead migration, care should be taken not to put excess
pressure on the implant location, especially in the immediate post-operative period. For example,
oxygen masks should be avoided in favor of intranasal oxygen.
Prior Surgical Procedures
Prior surgical procedures of the mid-face or anterior skull base may affect the proper implantation of
the Microstimulator. In addition, any metallic objects implanted in the mid-face may cause
interference with the SPG Microstimulator System. Physicians should assess these patients prior to
implanting the Microstimulator to determine if the proper implantation and usage of the SPG
Microstimulator System can be accomplished. Tooth fillings will not interfere with the System.
Post-Implant Medical Tests and Procedures
Medical procedures, devices or tests may damage or alter the SPG Microstimulator System. The
following procedures or tests should only be performed and the following devices should only be used
if the benefits outweigh the risks: facial nerve blocks (e.g., infra-orbital or maxillary), orthodontic or
dental procedures (e.g., tooth extractions or bridge implants), cosmetic procedures (e.g., lipectomy,
face lift, radiothermoplasty, laser skin removal, resurfacing or dermal fillers), and electrohydraulic
lithotripters.
The following procedures or tests should only be performed and the following devices should only be
used after talking to a doctor: facial nerve blocks (for example, infra-orbital or maxillary), orthodontic
or dental procedures, and cosmetic procedures.
Therapeutic Radiation
Therapeutic radiation may damage the electronic circuitry of the System. Sources of therapeutic
radiation include, but are not limited to: therapeutic x-rays, cobalt machines, and linear accelerators. If
radiation therapy is required, the area over the implanted device should be shielded with lead.
Implantable and External Devices
The interaction between the SPG Microstimulator System and other medical devices, including
pacemakers, defibrillators, neurostimulators, hearing aids and other implantable and external devices,
has not been characterized. If the patient requires such devices, the physician should consult
Autonomic Technologies for current information concerning the compatibility of such devices.
Cardiac Defibrillation/Cardioversion
The effect of internal or external defibrillation or cardioversion on the implanted Microstimulator is not
known. If a patient undergoes defibrillation, they should see their doctor to confirm their
Microstimulator settings before using their Remote Controller.
Electromagnetic Interference (EMI)
Certain commercial electrical equipment (for example, arc welders, induction furnaces, resistance
welders), communication equipment (for example, microwave programmers, linear induction motors,
linear power amplifiers, high-power amateur transmitters, and cellular phones), and high-voltage
