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Medtronic Nexframe Stereotactic System and StealthStation… recallZ-1995-2020 · Medtronic Navigation, Inc. · initiated Aug 9, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Navigation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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).

FDA root cause category: Software design

What the company is doing

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 [email protected] 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 [email protected] 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.

Recall details

Recall number
Z-1995-2020
Status
Terminated
Initiated by the company
Aug 9, 2019
Posted by the FDA
May 18, 2020
Recalling firm
Medtronic Navigation, Inc.
Quantity
61 customers purchased the specified combination of equipment which may lead to this error.
Product code
HAW
FDA submissions
K153660, K162309
Distribution
Worldwide distribution including US nationwide, Austria, Canada, Italy, Romania, Spain, and United Kingdom.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

36 devices cleared under K153660, K162309 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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