MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9735737, system version #: 1.2.0.No products have been returned for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that while setting up for a procedure, the 3d model and axial images appeared to be distorted.The local representative (cs) requested a new exam.The new exam looked fine on pacs but was almost as bad as the first once it was loaded onto the stealth.Exam was loaded via query.Technical services (ts) recommended to try loading the exam from a disc.No results from this troubleshooting have been reported.This was reported outside of a procedure.There was no patient involved.It was reported that to troubleshoot, the cs had the site do another mri.The results were better, but not ideal.The procedure was able to be done without issue. there is no resolution currently.It was reported that using a disk made no difference and images turned out the same as from the network.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that cause is unknown.

Manufacturer Narrative

Software logs and archives have been received.However, they are under analysis a the time of filing.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information that a manufacturer representative followed up with the radiology department to discuss the possibility of the scanner coil being the issue.It was determined that the scans with rippling came from the emergency department.The site reported that the scan did not follow the navigation system's protocol because they had a standard 5.00 mm spacing for these scans.The representative reported that the digital intercommunication of medicine (dicom) showed that the images did follow navigation system's protocol and suggested they did in fact have a 1.00 mm spacing.

Manufacturer Narrative

H3, h6: a software analysis was initiated to determine the probable cause of the issue.Analysis found that there was insufficient i nformation in order to determine a root cause.Fdm 10, fdr 213, and fdc 4315 are applicable to the software analysis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGN CART 9735665 STEALTH S8 PREMIUM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9978873
• MDR Text Key: 188361223
• Report Number: 1723170-2020-01271
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• Combination Product (y/n): N
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2020

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
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 04/06/2020; 05/13/2020; 06/23/2020
• Supplement Dates FDA Received: 04/20/2020; 05/18/2020; 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1