Medtronic's StealthStation DBS Software Subject of Class I Recall

Megan Brooks

June 01, 2020

Medtronic has recalled the auto-registration feature in the StealthStation deep brain stimulation (DBS) software because of inaccuracies during DBS procedures, according to a notice on the US Food and Drug Administration (FDA) website.

The StealthStation DBS software with the NexFrame stereotactic system and O-arm imaging system provides images of the brain to help surgeons navigate surgical tools and implants used during DBS.

The inaccuracies in the auto-registration feature of the software are caused by minor patient movements during the auto-registration process when used with NexFrame during a DBS procedure, which may go undetected by the surgeon or the device system, the FDA says.

"This may provide inaccurate registration data, which could lead surgeons to inaccurately navigate lead placement during image-guided DBS procedures. This could result in serious or life-threatening patient harm," the agency warns.

The FDA has identified this as a Class I recall, the most serious type, because of the risk of serious injury or death. To date, this issue is the subject of 33 medical device reports: 22 related to device malfunction and 11 related to injuries.

The recall covers software version 3.0 or newer (3.0, 3.1, 3.1.1) with StealthStation DBS license or StealthStation S8 software with Stealth DBS license. The software was distributed between February 1, 2016 and May 1, 2019.

Medtronic has notified all customers with the affected product about the recall via an urgent medical device correction letter. The letter advises users to weigh the benefits vs risks of fiducial-based or fiducial-less registration methods and provides the following instructions:

Following the O-arm auto-registration step, but prior to using the StealthStation DBS software with the NexFrame stereotactic system and O-arm imaging system for intraoperative navigation:

1. Assess navigational accuracy by verifying the accuracy of the registration on several known anatomical landmarks, as described in the indications for use, before using the registration for navigation.

2. Use the StealthMerge functionality in the software, as described in the indications for use, to compare the actual location of the cannula or lead to the surgical plan.

3. Use the planning functionality in the software, as described in the indications for use, to compare the cannula to planned trajectory. This can be accomplished by making an additional plan along the axis of the cannula to evaluate cannula position.

The FDA is continuing to work with Medtronic to determine whether additional mitigations may be needed.

Healthcare professionals and distributors with questions about this recall should contact Medtronic by phone at 1-888-826-5603 or email at rs.navtechsupport@medtronic.com.

Adverse reactions or quality problems related to this recall should be reported to the FDA's MedWatch program.

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