MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Perforation (2001); Spinal Column Injury (2081); Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

Patient age and weight were not available from the site.On 02/01/2017 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.Return requested.Replacement positioning sensor unit (psu) shipped to site 01/31/2017.Medtronic investigation of returned suspect psu finds it to be in good condition with no apparent physical damage.A check of the event log did not reveal any adverse events.The psu passed an accuracy assessment at.16 mm with a passing threshold of.35 mm.The psu is fully functional and not the source of the alleged inaccuracy.Device found to be fully functional.No fault found.No further issues have been reported.

Event Description

A medtronic representative received a report that, while in a spinal fusion cervical procedure on (b)(6) 2017, the surgeon alleged an inaccuracy of 2.5 - 3.3 millimeters occurred during two imaging system spins.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no delay of therapy reported.There was no impact on patient outcome.In trouble-shooting at the site on (b)(6) 2017, the medtronic representative registered a demo head using tracer and when checking accuracy, was 2.5 - 3.3 millimeters off.An imaging system registration resulted in the same inaccuracy.In checking camera logs, there were no failures identified.It is deemed likely there was possible camera damage, as the site registered nurse (rn) noted that the camera had been bumped a few times.

Manufacturer Narrative

Correction: there was a reported delay to the procedure of less than 1 hour due to this issue.

Manufacturer Narrative

Additional information: the surgeon was actively navigating when the inaccuracy was noted and an incision had already been made.There were two screws misplaced in the disc space.Active good navigation was never recovered and the surgeon opted to complete the procedure without the use of the navigation system.The screws were replaced without the use of the navigation system after approximately 15 minutes.No adverse effects occurred with the patient due to this issue and replacement of the screws.Additional information: a medtronic representative went to the site to test the imaging equipment used in the procedure.Completed 3d spins and transferred data to the navigation system, used contrast phantom to verify accuracy on both left and right sides.The imaging then passed the system checkout and was found to be fully functional.The medtronic representative reported that she was able to replicate the inaccuracy by doing a tracer registration, followed by a point merge registration in the cranial software.She used the passive probe & cranial frame and found it was inaccurate by 2-3mm.She did 2 different imaging system spins using her spine model and the results were the same.2-3mm off.She then replaced the camera and performed the same tests and was found to be accurate.The medtronic representative then returned to the site and used the original frame from the procedure and was also found to be accurate with the new camera/positioning sensor unit (psu).There have been no further inaccuracy issues reported since replacement.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: oksana ditolla ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6359020
• MDR Text Key: 68372285
• Report Number: 1723170-2017-00766
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/22/2017; 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention