Recall – Brain stimulation placement inaccuracies due to software

Company: Medtronic Navigation, Inc.
Date of Enforcement Report: 6/10/2020
Class II

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.

Recall Number: Z-1995-2020

REASON

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).

RECALLING FIRM/MANUFACTURER

Medtronic Navigation, Inc. on 8/9/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

61 customers purchased the specified combination of equipment which may lead to this error.

DISTRIBUTION

US Nationwide and International

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