MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Output Problem (3005)

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

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that wiggling the camera cart would cut out communication with the camera.The camera cable was replaced.It was reported that replacing the cable did not resolve the issue.The representative switched the camera with a different system's camera and the issue resolved.An attempt was made to check the tool box, but it was not possible to open the tool.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 being used for a sacroiliac and thoracolumbar procedure.It was reported that pre-operatively, the system would not view the patient reference frame continuously.The site rebooted the system without resolution.The system continued to track the reference frame intermittently.The finished the case with a different system.There was no reported impact to patient outcome.There was a reported delay to the procedure of less than one hour due to this issue.

Manufacturer Narrative

Concomitant medical product: section d information references the main component of the system.Other relevant device(s) are: product id: 9735821, serial/lot #: (b)(6), ubd: unknown, udi#: unknown.H3: system: a medtronic representative visited the site to evaluate the equipment.The camera cable was replaced due to a break in the cable.It was found that the camera was broken as well.The camera and cable were replaced and damaged parts were shipped back.Codes 10, 114, and 4307 are applicable.H3: concomitant product: product id: 9735821: the returned psu powered up on the test bench without the amber fault light but a check of the event log showed intermittent firmware incompatibility issues and intermittent illuminator current low.The psu also failed an accuracy test (aak) at.46 mm with a passing threshold of.25 mm.This psu has not been previously returned for a failure.Codes 10, 114, and 4307 are applicable.H3: product analysis: product id: 9735843: one of the returned cables within the kit had a small cut in the cable jacket exposing the shield wire but no bare conductors.Otherwise, all the cables in the kit passed a continuity test with no opens or shorts detected.No problem found.Codes 10, 213, and 67 are applicable.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: STEALTHSTATION S8 PREMIUM SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9801813
• MDR Text Key: 184074032
• Report Number: 1723170-2020-00783
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

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?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 75