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

Model Number 9735665

Device Problems Imprecision (1307); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information has been requested, but not yet received.Concomitant medical products: product id: 9735740, software version: 1.2.0.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a sacroiliac and thoracolumbar procedure.It was reported that the site was inaccurate during a case.They had just completed an ¿xlif¿ and had the patient lateral.They were using a perc pin placing posterior screws ¿mas.¿ they did a spin and placed the screws, however on another spin they were inaccurate and on a different level.The stealth screen flickered briefly at the time.They were able to re-place the screws.There was no patient impact related to this event.

Manufacturer Narrative

Device evaluation: logs were reviewed but provided insufficient information to determine root cause of the reported behavior.Method/result/conclusion codes are applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the surgeon was using percutaneous screws.

Manufacturer Narrative

A medtronic representative visited the site to evaluate the equipment.The rep tried to replicate the issue many times, but found no inaccuracies.The rep concluded that the issue was due to user error.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.

Event Description

Additional information received: after the first spin and immediately before dropping the first plan using the thoracic awl, there was a visual disturbance on the monitor which was described as a 'flicker'.It was noted that the entire screen 'scrambled and jumped' for a second.The physician stated they did not move their hands from the level they had initially begun to plan, however when he looked at the monitor it was at one level away from where they had initially shown on the screen.The physician continued believing they were accurate according to the screen based on "feeling bone where the system showed" and proceeded as normal.However after the second spin, it was observed that the screws were placed one level away than intended.There was a reported 20 minute delay to the procedure to remove and replace the screws as a result.

Manufacturer Narrative

H2: correction: a1-a5 patient information updated b5.Additional information updated 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: 9503825
• MDR Text Key: 188044886
• Report Number: 1723170-2019-06113
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 89