MARYLAND – A device designed to help with brain surgery and analysis has been recalled by the FDA. It is a class 1 recall, which means use of these devices may cause serious injuries or death.
The Stealthstation auto-registration feature has been recalled due to inaccuracies during deep brain stimulation procedures (DBS).
The DBS Software provides images of a patients brain to help surgeons navigate surgical tools and implants used during a deep brain stimulation (DBS) procedure.
According to the FDA, ” Medtronic has recalled the auto-registration feature of the StealthStation DBS Software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame during a DBS procedure, which may not be detected by the surgeon or the device system.
What this does in simple terms is a surgeon tries to place leads that help in mapping a patients brain could be pushed into the wrong place resulting in serious or life threatening harm to the patient.
As of June 2020, a total of 33 medical device reports were identified: 22 related to the device malfunction, and 11 related to the injuries.
This is a video on YouTube that shows how the device is supposed to work.
For more information about the recall go to the FDA’s website