MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	I7
Medical Device Problem Codes	Imprecision (1307); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Tissue Damage (2104); Brain Injury (2219); Iatrogenic Source (2498)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No parts have returned to the manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that while in a cranial resection procedure an alleged inaccuracy occurred with the navigation system.After registering and checking accuracy, the surgeon felt that they were accurate and continued with a tumor resection.However, following the resection, the surgeon took an imri scan which they merged with the pre-op mr and they saw that the tumor was still visible in the intraoperative magnetic resonance imaging (imri) scan and none of it had been removed.The surgeon then checked the accuracy on the imri and it was accurate.The area resected was reported to be very close to the actual location of the tumor but was at least 5mm off.The site then took a small sample and decided to close and will take an image on a following day.There was a reported delay to the procedure of less than 1 hour due to this issue and the patient was affected as a result.
Additional Manufacturer Narrative
Additional information: a full system check-out was completed and all tests passed.Reported event could not be replicated.Full system functionality was confirmed and the system was returned to service.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7180784
• Report Number: 1723170-2018-00178
• Device Sequence Number: 16459024
• Product Code: HAW
• UDI-Device Identifier: 00643169486645
• UDI-Public: 00643169486645
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2018

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
• Operator of Device: Physician
• Device Model Number: I7
• Device Catalogue Number: 9734060
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 02/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Weight: 91