abbott proclaim spinal cord stimulator mri safety

Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Poor surgical risks. Using surgical instruments. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The system is intended to be used with leads and associated extensions that are compatible with the system. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. This may occur once the lead is in place and is connected to the neurostimulator and activated. Confirm the neurostimulation system is functioning. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Expiration date. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. Reducing the Pains of Chronic Pain Treatment | Abbott Newsroom The equipment is not serviceable by the customer. If interference occurs, try holding the phone to the other ear or turning off the phone. FDA approves new MRI compatibility for Abbott's Proclaim spinal cord Radiofrequency or microwave ablation. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. INDICATIONS FOR USE Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. Patients should cautiously approach such devices and should request help to bypass them. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting.

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