—#180357

Product

Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure. Neurological stereotaxic Instrument.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K153660, K162309
Affected lot / code info: Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS procedure. Stealthware Station Cranial Software GTIN(s): 00643169878204, 00643169625549 O-Arm Imaging System GTIN(s): 00763000068073, 00763000068080, 00763000068097, 00763000068103, 00763000074050, 00763000074067, 00763000074074, 00763000074081, 00763000074098, 00763000074104, 00763000074111, 00763000074128, 00763000074135, 00763000079000, 00763000079017, 00763000079024, 00763000079031, 00763000079048, 00763000079055, 00763000079062, 00763000079079, 00763000079086, 00763000079093, 00763000079109, 00763000079215, 00763000079246, 00763000079260, 00763000080969, 00763000080976, 00763000080983, 00763000080990, 00763000081003, 00763000081010, 00763000081027, 00763000081034, 00763000081041, 00763000081058, 00763000081065, 00763000081072, 00763000081089, 00763000081096 and 00763000081102. Nexframe Stereotactic System GTIN(s): DB-2040, 00643169214811; MI-1000, 00643169986763; MI-2000, 00643169986770; NP-1000, 00613994747877.

Why it was recalled

Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).

Root cause (FDA determination)

Software design

Action the firm took

Urgent Medical Device Correction Letters were sent to U.S. customers via FedEx Overnight with signature required at delivery beginning on August 9, 2019. European consignees were first notified via registered mail and/or personal visits by Medtronic representatives starting August 27, 2019. The one Canadian consignee was first notified via registered mail starting August 19, 2019. Customers were informed of which devices, when used in combination, can result in entry point and lead placement inaccuracies during Deep Brain Stimulation (DBS) lead implantation procedures. Customers were instructed to: 1. determine which registration method, auto-registration (fiducial-less) or manual registration, is appropriate considering the information in the Urgent Medical Device Correction Letter, 2. assess navigational accuracy on several known anatomical landmarks before using the registration for navigation, 3. use the StealthMerge functionality in the software to compare the actual location of the cannula or lead to the surgical plan, 4. use the planning functionality in the software to compare the cannula to planned trajectory, 5) sign and date the Customer Confirmation Form, and return the form to Medtronic via email at RS.NavFCA@Medtronic.com or via fax at 651-367-7075 within 30 days of receipt. Neurosurgeon users were informed that a Medtronic representative would contact them regarding training available to provide an overview of this issue. Users were requested to register for and complete the training. Customers were instructed to report adverse events or quality problems experienced with the product to FDA and Medtronic as follows: E-mail Medtronic at rs.navtechsupport@medtronic.com or call 1-888-826-5603; Online at the FDA website2 (form available to fax or mail) or call FDA at 1-800-FDA-1088. Customers with questions were instructed to contact Medtronic at 1- 888-826-5603.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: Worldwide distribution including US nationwide, Austria, Canada, Italy, Romania, Spain, and United Kingdom.

Timeline

Recall initiated: 2019-08-09
Posted by FDA: 2020-05-18
Terminated: 2024-04-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180357. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.