MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 EM CRANIAL SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9735668
Medical Device Problem Codes	Imprecision (1307); Poor Quality Image (1408)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned to the manufacturer for analysis.Part not returned.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a cranial resection.It was reported that images were missing slices along with bad image quality.Site successfully registered the patient but were inaccurate when verifying registration.Auto-refine attempted without resolution.There was no impact to patient.There was a reported delay to the procedure of less than 1 hour due to this issue.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the system performed as intended and no hardware parts were replaced.The system then passed the system checkout and was found to be fully functional.The patient archives were sent to the manufacturer and upon review, it was discovered that the patient had 9 registrations with error metrics above 1.9.All of the trace registrations showed the pattern of the nose off onto the patients left cheek.The model of the exam appeared to have missing slices shown as solid block.The quality of model most likely caused trace registration to be inaccurate.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The navigation system was checked out with no findings.The patient archives were reviewed, showing that the exam was missing slices, and provided photos showed that the exam was labeled as "not optimal for stealth." there were no indications of a software malfunction.Engineering commented that the site did not likely adhere to imaging protocols.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 EM CRANIAL SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7853264
• Report Number: 1723170-2018-04435
• Device Sequence Number: 1950436
• Product Code: HAW
• UDI-Device Identifier: 00643169877016
• UDI-Public: 00643169877016
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9735668
• Device Catalogue Number: 9735668
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/13/2018; 08/13/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 11/05/2018; 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 79