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Algovita Spinal Cord Stimulation System
Trial Stimulator Manual
7
Interaction with Implanted Sensing Stimulators and Other Implanted Devices.
SCS systems
may interfere with the operation of implanted sensing stimulators such as pacemakers or
cardioverter defibrillators (ICDs). If other implanted devices are indicated for the patient, careful
screening is required to determine if safe results can be achieved before permanently implementing
concurrent electrical therapies. The effects of implanted SCS systems on other implanted devices
are unknown.
Magnetic resonance imaging (MRI).
Patients with the Algovita SCS system must not be exposed
to MRI. The electromagnetic field generated by an MRI may forcefully dislodge the IPG or leads,
damage the IPG electronics, and induce voltage through the lead that may cause an uncomfortable
or jolting sensation or serious injury. The Algovita SCS System components have not been tested
for heating or migration in the MR environment. Introducing an Algovita SCS patient into an MRI
scanner may result in severe patient injury, death, or device malfunction.
Modification.
Do not modify the EPG. Modification of any SCS system component may result in
damage to the system, compromised system integrity, and harm or injury to the patient.
Radio-frequency or microwave ablation.
Safety has not been established for radiofrequency (RF)
or microwave ablation in patients who have an SCS system. Induced electrical currents may cause
heating, especially at the lead electrode site, resulting in tissue damage.
Precautions
System Interaction with Other Medical Treatments and Procedures.
An IPG may interact with
the following therapies or procedures:
•
Diagnostic x-rays.
The effects of diagnostic x-rays on a stimulator are typically transient
because interference occurs only during the time of x-ray exposure. In some cases, the EPG
may need to be reprogrammed.
The following therapies or procedures may turn your stimulation off or may cause permanent
damage to your stimulator, particularly if used in close proximity to the EPG.
•
Radiotherapy
•
Lithotripsy
•
External defibrillation
•
Radiation therapy
•
Ultrasonic scanning
•
High-output ultrasound
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