MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9733856 S7 STAFF ASSEMBLED 110V; INSTRUMENT, STEREOTAXIC

Model Number 9733856

Device Problem Output Problem (3005)

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

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative visited the site to evaluate the equipment.Neither the issue with the camera nor the frame could be replicated.The rep checked the camera logs and removed and re-seated the camera cable.The rep removed the arm covers and checked for loose or frayed connections.There were no visible issues.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 site was having issues with the reference frame disappearing during the case.They stated that during the case they had held the camera in place and the system would flicker with the frame in view.There was a patient was present.The site was still able to use the system to finish the case.It was reported that there was a delay to the procedure of fifteen minutes.

Manufacturer Narrative

H2: additional information was received.See b5.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 was received.It was reported that only the reference frame was flickering.This was not observed with any other instruments. .

• Brand Name: CART 9733856 S7 STAFF ASSEMBLED 110V
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10089402
• MDR Text Key: 192149601
• Report Number: 1723170-2020-01517
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 105