Deep Brain Stimulation Safety and Use
If you are considering or have received deep brain stimulation (DBS) therapy with a device like the St. Jude Medical Infinity™ DBS system, it is important that you understand safety information about your system. Read all product guides that you receive for complete information about your DBS system.
DBS therapy is not for everyone, so it is important to talk with your doctor about the benefits and risks. As with any surgery or therapy, DBS has risks and complications.
The risk of serious side effects from DBS is low, particularly with an experienced surgical team. Most side effects of DBS surgery are temporary and correct themselves over time. However, some complications can be more serious and/or permanent.
Risks of brain surgery may include serious complications such as coma, bleeding inside the brain, paralysis, seizures and infection. Some of these may be fatal. Once implanted, the area around the system may become infected, parts may wear through your skin and the lead or lead/extension connector may move. Any of these situations may require additional surgery or cause your symptoms to return.
While most complications will have no after-effects, some people may experience lasting, stroke-like symptoms, such as weakness, numbness, problems with vision or slurred speech. In the event that side effects are intolerable or you are not satisfied with the therapy, the DBS system can be turned off or surgically removed.
See important safety information for the St. Jude Medical Infinity DBS 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.
Infinity™ DBS 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 an Infinity™ 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 Infinity™ neurostimulation system.
St. Jude Medical sent the following letter to patients who have an implantable pulse generator (IPG) device.
Important Medical Device Advisory: Proclaim™ Elite SCS and Infinity™ DBS Neurostimulation Systems (35kb)