Medtronic StealthStation S Surgical Navigation Station

2023: Medtronic admitted to selling defective surgical systems. Patients may die because of them

On December 19, 2023, the US Food and Drug Administration (FDA) reported that a serious defect was detected in Medtronic's StealthStation S8 surgical navigation systems. The use of defective equipment can harm the health of patients or even provoke death.

The StealthStation S8 complex can be used during operations, when the use of stereotactic surgery is advisable. This is an intervention method in which access to a target point within a body or tissue thickness of an organ is performed in accordance with a spatial scheme at pre-calculated coordinates. In this case, the StealthStation S8 helps track the location of surgical instruments and adjust their movement with high accuracy according to a predetermined plan.

Medtronic StealthStation S8

The identified problem is due to the fact that the software of the StealthStation S8 systems can malfunction, as a result of which a violation of the surgical plan occurs. This can lead to incorrect actions of doctors, which creates a risk to the health of patients. Since StealthStation S8 complexes are used in high-precision operations, the development of critical conditions, including death, is not excluded.

The defect affects the StealthStation S8 complexes with software versions 2.0 and 2.0.1. Such products were delivered from January 7, 2022 to October 2, 2023. In total, more than 2,100 devices are affected. As of December 19, 2023, cases of harm to health or deaths due to the use of equipment were not recorded. The problem will be fixed by releasing an updated version of the software.^[1]

2020: Medtronic recalls software for deep brain stimulation systems

In early June 2020, it became known that Medtronic is recalling software used in deep brain stimulation systems. The recall is assigned to the first class group, that is, the software threatens the life and health of patients.

The StealthStation system is used by surgeons to accurately position anatomical structures in open or percutaneous neurosurgical procedures, including deep brain stimulation procedures. In August 2019, the company began receiving messages related to StealthStation software malfunctions. They occurred during the automatic registration of signals when using this software together with the NexFrame stereotactic system during the deep brain stimulation procedure.

Medtronic recalls software used in deep brain stimulation systems

The malfunction led to the development of injuries in 11 people. Medtronic recommended that doctors weigh the benefits and risks of the procedure before performing it and provided additional instructions that allowed for more precise control of the patient's position. Now Medtronic is fully recalling StealthStation DBS software version 3.0 or newer (3.0, 3.1, 3.1.1) and StealthStation S8 software with the Stealth DBS license, which was distributed from February 1, 2016 to May 1, 2019.

In August 2019, Medtronic received reports of possible problems with automatic registration when using StealthStation software during deep brain stimulation procedures, said Medtronic spokesman David T. Young. - Problems were associated with involuntary movements of the patient in connection with breathing or tremor after the start of registration, but before receiving the image. Medtronic initiated a medical device fix and notified users of the alleged problem. All measures taken were carried out and completed.[2]

2019: Medtronic recalls defective 3D brain imaging software

In early January 2019, Medtronic recalled Synergy and StealthStation S7 3D brain imaging software, which is used with the StealthStation Surgical navigation system. The reason for the software recall was reports of incorrect display of information received by specialists during biopsy procedures. Regulatory authorities have designated the identified problem as a Class I threat. This is the most serious class of threats that designate cases where the use of a product can lead to serious adverse health effects or even death of the patient.

Synergy and StealthStation S7 3D brain imaging software is designed for use with the StealthStation Surgical navigation system, also developed by Medtronic. This software allows detailed 3D images of the patient's brain, which are designed to facilitate the orientation of the neurosurgeon during surgery and determine the exact location of the instrument in the brain of the patent. The manufacturer notes that the StealthStation S7 surgical navigation system has an intuitive interface, software for quick patient registration and advanced imaging in various neurosurgical procedures. The system has optical and electromagnetic tracking functions and integrates with external devices such as microscopes, ultrasound machines and various tools manufactured by Medtronic.

In early January 2019, Medtronic recalled Synergy and StealthStation S7 3D brain imaging software, which is used with the StealthStation Surgical navigation system

According to the reports received, the defective software during the biopsy may incorrectly inform the specialist that the tip of the surgical instrument has not yet reached the planned goal. In such a case, the neurosurgeon may run the surgical instrument too deep and damage healthy brain tissue or blood vessels, as indicated in the FDA notice.

After receiving such reports, regulators called Medtronic to account. According to the FDA notice, Medtronic must recall defective software installed on 5,487 pieces of equipment. The recall applies to Synergy software with model number 9733763 and software versions 2.2.0, 2.2.5, 2.2.6 and 2.2.7 and Stealth Station S7 with model number 9735585 and software versions 3.0.0, 3.0.1 and 3.1.0. At the request of the regulatory authorities, the software developed and distributed from August 31, 2011 to October 16, 2018 is subject to recall.

Medtronic began notifying users of the software recall on September 21, 2018. At the same time, the company introduced measures to reduce or eliminate the risk of damage to healthy tissues during the use of this software. Medtronic advised operators to customize the equipment for a specific type of operation, follow the instructions of pocket recommendations for this software and always use a mechanical depth limiter for the biopsy needle. It is also recommended that you ensure that the correct tool is selected in the program before you begin the operation.

In 2010, StealthStation S7 software was already trying to be recalled, but then the regulatory authorities considered the problem less serious and attributed it to class II threats. At that time, the problems were associated with excessive wear of the power cord, which could lead to incorrect operation of the device or electric shock to the user. Regulators have reminded health care professionals and patients that they can report adverse events or quality-related issues with these devices using the online MedWatch form, the FDA's adverse event awareness program, and by regular mail or fax.^[3]

2017: StealthStation S8

In April 2017, Medtronic introduced the StealthStation S8 surgical navigation station. The equipment is a universal platform for conducting all types of interventions in neurosurgery and spinal surgery, in traumatology, ENT surgery and prosthetics of the knee and hip joints.

The station incorporated all the best that was used in previous StealthStation models, as well as several new developments by Medtronic. Updated and revised versions of the navigation software, transferred to a single Synergy platform, allow each surgeon to personally specify the list of operations performed, the equipment used, the tool, as well as the format of equipment placement in the operating room.

StealthStation S8 Surgical Navigation Station

A new neurosurgical navigation system allows you to calculate the least traumatic path to a tumor located in the deepest corners of the brain or spinal cord, and get to it with minimal injuries.

The StealthStation S8 includes 3D cameras and electromagnetic sensors to track the location of instruments, appropriate control algorithms and software to process data coming from various sources. A terabyte solid state drive is provided for data storage.

The novelty can connect to MRI and CT scanners, fluoroscopes and the Medtronic O-arm X-ray system. There are two 27-inch touchscreen displays, thanks to which doctors can control equipment like smartphones or tablets. A large amount of RAM (16 GB) speeds up the processing of medical images and their display on the screen.

The device supports wireless connection to medical devices. The operating system adapts the image to Full HD (1920 x 1080 pixels) and a 16:9 aspect ratio.

The start date for the StealthStation S8 at the time of the product announcement has not been announced.^[4]

2012: StealthStation S7

Medtronic, Inc. in September 2012 announced the appearance in Russia of the StealthStation S7 surgical navigation station with an application for ENT surgery.

The surgical navigation system is a universal hardware platform for conducting all types of interventions in both neurosurgery and spinal surgery, as well as in traumatology, ENT surgery and prosthetics of the knee and hip joints. Allows real-time surgical navigation when using X-ray images.

StealthStation S7 Surgical Navigation Station

Updated and revised versions of the navigation software, transferred to a single Synergy platform, allow each surgeon to personally specify the list of operations performed, the equipment used, the tool, as well as the format of equipment placement in the operating room. This flexibility reduces the preparation time for the operation.

The system software converts CT (computed tomography) or MR (magnetic resonance) images obtained before the operation, or X-rays obtained during the operation, and outputs them in different projections (axial, sagittal, crown, inclined) to the screen - a large high-definition monitor that provides the surgeon with access to information of interest to him. All configuration and preparation operations are performed on the assistant module, where an additional monitor, mouse, keyboard and other necessary controls are installed.

With the help of the system, the surgeon can create, save and simulate a scenario for moving along one or more trajectories before the operation. For greater clarity, the surgeon may also create and use one or more three-dimensional anatomical models. During the operation, the system monitors the movement of special surgical instruments located on top or inside the anatomical areas, and constantly updates the position of these instruments on the screen.

If necessary, the program also displays the relationship between the actual position/movement of the instruments and the preoperative plan, directing the surgeon's actions according to a predetermined trajectory.^[5]

When designing the navigation station, Medtronic specialists focused on the formation of a single surgical complex, part of which is the navigation station. Thus, it implements the principle of simple and intuitive integration with a wide range of various surgical equipment, ranging from coagulators and exhausts, to equipment for intraoperative imaging.^[6]

Thanks to its simplicity and individual settings, the StealthStation S7 navigation system allows for more efficient neurosurgical interventions. It establishes the operational process and helps to reduce the inconvenience associated with the high complexity of neurosurgical operations and the problem of training constantly changing personnel. The emergence of such innovative equipment in Russian clinics is a vivid example illustrating the program of modernization of Russian healthcare in action, "said Elena Plyasunova, General Director of Medtronic in Russia.

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