WASHINGTON, D.C. — The U.S. Food and Drug Administration, or FDA, announced a Class 1 recall for a medical device used during brain surgery. Regulators with the FDA recalled a device identified as the StealthStation auto-registration, which is manufactured by Medtronic. This device required recall because its analysis was inaccurate when used during stimulation procedures of the deep brain (DBS). Surgeons use the DBS software to give them accurate images of a patient’s brain so that they can accurately navigate their tools and implants they used during deep brain stimulation, according to a report appearing on WRBL.com. According to Medline Plus, DBS is a process by which surgeons introduce a neurotransmitter into the brain that controls pain, weight, movement, awakening from a coma, and obsessive-compulsive thoughts.
The FDA’s designation of this recall as a Class I signifies the dangers associated with the malfunctioning medical device. Medtronic was forced to institute the recall program after the auto registration component of the devious software was found to create inaccuracies when a patient moved during the auto registration procedure of brain surgery. Surgeons use a device called NexFrame during the DBS procedure. The minor movements of the patient may not be detected.
During the procedure, surgeons attempt to place electrical wires on the surface of the brain to help map the patient’s brain. If the mapping is incorrect, then a lead could be pushed into the wrong area of the brain. That error could cause significant injury to the patient or kill the patient as a result of the misplaced lead.
At this time, Medtronic received 33 adverse incident reports. Twenty-two of the reports related to a malfunctioning device. The remaining eleven incident reports noted patient injury. Neither Medtronic nor the FDA explained the severity of the injuries the patients sustained or whether any of them died during the procedure.
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