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 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.
With an implanted device, it is important to be aware of electromagnetic interference or EMI, which is produced by certain medical procedures including MRI/MRA scans. Learn more about MRI scans and EMI interference.
Find more specific safety and use information for our neuromodulation systems:
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)
Eon™ Charging System exchange
St. Jude Medical recently provided doctors and patients with information and instructions for exchanging older Eon charging systems (Models: 3701 and 3711) for the new Model 3726. This action is an update to the initial Eon and Eon Mini™ charging system announcement and corrective action that began in July 2012. St. Jude Medical is sending out the following letter to patients with an Eon charging system.
Important Medical Device Safety Information Eon™ Charging System July 2014 (260kb)
Eon™ and Eon Mini™ Charging Systems
St. Jude Medical recently provided doctors and patients with information about their Eon and Eon Mini Charging Systems (Models: 3701, 3711, and 3721).
If you have an Eon or Eon Mini Charging System and you have any questions or concerns, please contact your St. Jude Medical representative or St. Jude Medical Neuromodulation Division at 1-866-240-6741. St. Jude Medical sent the following letter to patients who have an Eon or Eon Mini Charging System to inform them about this issue:
Important Patient Information Eon and Eon Mini Charging Systems July 2012 (48.7kb)
We regret any concerns that this may cause you or your family. St. Jude Medical is dedicated to providing the most reliable medical products and will continue to work closely with your physician to ensure that we provide all of the latest information to continue to manage your spinal cord stimulation system in the best possible way. If you have any questions or concerns, please contact your St. Jude Medical representative or St. Jude Medical Customer Service at 1-866-240-6741.