A recall has been issued for Medtronic guidance systems, which are used during deep brain stimulation procedures, after the manufacturer identified inaccuracies in the imaging data that could result in a risk of serious and potentially life threatening injuries.
The FDA announced the Medtronic StealthStation recall on June 1, giving it a Class I designation, after dozens of reports were received involving imaging inaccuracies that have resulted in at least 11 patient injuries.
The recall involves the StealthStation DBS Software with the NexFrame Stereotactic System and O-arm Imaging System, which are designed to provide images of a patient’s brain to help surgeons navigate surgical tools and implants during deep brain stimulation procedures.
According to the recall announcement, the StealthStation software may provide inaccurate imaging data caused by minor patient movement during the registration process, which may go undetected by the surgeon or the device system. In the event the registration data is incorrect, surgeons could place leads in the wrong location during deep brain stimulation procedures, significantly increasing the risk of injury.
Medtronic first issued an Urgent Medical Device Correction letter on August 9, 2019, informing customers of the risks and advising physicians to weigh the benefits versus the risk of using the imaging system. The notice instructed physicians to assess navigational accuracy by verifying the accuracy of the registration data on several known anatomical landmarks.
As of June 2020, the FDA and Medtronic have become aware of 33 medical device reports in which 22 were related to a device malfunction, resulting in at least 11 patient injuries.
Due to the adverse reports, the FDA upgraded the Medical Device Correction to a Class I recall, indicating it is the most serious type of recall and that the use of the product has a high probability of resulting in serious injury or death to patients.
The recall includes the StealthStation Auto-registration Feature from the Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License. The devices and software were manufactured by Medtronic and were distributed to surgical centers across the U.S. from February 1, 2016 through May 1, 2019.
Medtronic has updated its training program for the use of the devices to include how to detect inaccuracies due to undetected patient motion. The company has announced it will continue working closely with the FDA to determine additional changes needed to increase patient safety.
Customers with questions or concerns regarding the recall are encouraged to contact Medtronic at 1-888-826-5603 or email firstname.lastname@example.org.
The FDA is asking professionals and consumers to report any and all adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting Program.