Device 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.
Z-1995-2020
Product summary
- Event
- Event 85243
- Status
- Terminated
- Classification
- Class I
- Quantity
- 61 customers purchased the specified combination of equipment which may lead to this error.
- Official record key
device-enforcement:Z-1995-2020
Official wording
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).
Code information: 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.
Distribution pattern: Worldwide distribution including US nationwide, Austria, Canada, Italy, Romania, Spain, and United Kingdom.
Derived failure modes
-
Device software or design
software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate