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Medtronic Recalls a StealthStation Software Feature Following Reports of Injuries during Deep Brain Stimulation (DBS) Procedures

By Burg Simpson
June 8, 2020
2 min read

On June 1, 2020, the FDA announced that Medtronic has recalled the auto-registration feature of its StealthStation deep brain stimulation (DBS) software due to accuracy issues that could result in life-threatening harm to patients undergoing DBS procedures. Surgeons rely on the StealthStation DBS software working together with Medtronic’s NexFrame Stereotactic System and O-arm Imaging System to develop images of a patient’s brain to assist with the navigation of tools and implants used during a DBS procedure. A malfunction or failure of the brain imaging software could have grave consequences, especially given the high stakes involved in a brain surgery.

Unfortunately, Medtronic’s StealthStation brain imaging software has been reported to malfunction and potentially leading to patient injuries during DBS procedures.  According to the FDA’s recall notice, minor patient movements during the “auto-registration process” could go undetected by the surgeon or the device system. The auto-registration process is used to map the patient’s brain prior to the operation. If a patient’s movements go undetected during this process, the device could provide inaccurate registration data that could lead surgeons to inaccurately navigate the tools and implants used during a DBS procedure. This could result in severe physical harm, the FDA warns. Indeed, the FDA has received at least 11 reports of injury associated with the Medtronic Stealthstation DBS software. Accordingly, the FDA has labeled this a Class I recall, its most serious designation.

If you or a loved one has suffered injuries during a DBS procedure you suspect were caused by the recalled Medtronic StealthStation software, contact one of the experienced product liability attorneys at Burg Simpson’s Cincinnati office today. Burg Simpson’s award-winning medical device team has a proven history of results for thousands of clients nationwide, and possesses the knowledge and resources to investigate your potential claim. Call 513-852-5600 or fill out our contact form for a FREE no-obligation consultation today!

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