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

Model Number I7

Device Problems Imprecision (1307); Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); Brain Injury (2219); Iatrogenic Source (2498)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

No parts have returned to the manufacturer for evaluation.

Event 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.

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
• 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: sam saleh ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7180784
• MDR Text Key: 96930426
• Report Number: 1723170-2018-00178
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169486645
• UDI-Public: 00643169486645
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: I7
• Device Catalogue Number: 9734060
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2011
• 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): Other
• Patient Age: 55 YR
• Patient Weight: 91