Neurostimulation Therapy Safety and Use
If you are considering or have received neurostimulation therapy, it is important that you understand safety information about your system. Read all product guides that you receive for complete information about your neurostimulation system.
Neurostimulation is not for everyone, so it is important to talk with your doctor about the benefits and risks. As with any surgery or therapy, neurostimulation has risks and complications.
What are the risks of neurostimulation?
Potential risks associated with a neurostimulation procedure and/or the use of a neurostimulation system include infection, swelling, bruising, undesirable changes in stimulation and the loss of strength or use in an affected limb or muscle group, even paralysis. Talk with your doctor about the possible complications associated with neurostimulation.
Find more specific safety and use information for our neuromodulation systems:
Prodigy MRI™ Chronic Pain System
Proclaim™ Elite Recharge-free IPG
St. Jude Medical™ Invisible Trial System
Axium™ Neurostimulator System
St. Jude Medical is committed to presenting information with accuracy and integrity. Occasionally we discover product issues that we feel are important to share with patients and their doctors. We will publish notices here.
Proclaim™ Elite SCS Implantable Pulse Generator (IPG)
St. Jude Medical recently provided doctors and patients with information and instructions for updating software for implantable pulse generator (IPG) devices. If you have a Proclaim™ Elite SCS IPG implanted before June 2, 2017, there is a software update for the new “Surgery Mode” software feature that applies to your device.
Learn how to download the software upgrade for Proclaim™ Elite SCS neurostimulation system.
St. Jude Medical sent the following letter to patients who have implantable pulse generator (IPG) devices.
Important Medical Device Advisory: Proclaim™ Elite SCS and Infinity™ DBS Neurostimulation Systems (35kb)