MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number UNK_NAV_SYS

Device Problem Human-Device Interface Problem (2949)

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

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9660651r, serial/lot #: unknown.Unique device identifier (udi) is unavailable.Onsite functional and visual examination was performed by a manufacturer representative.Hardware parts were replaced and the issue was resolved.The system passed a system checkout and was returned to an operational condition.Device manufacture date is unavailable.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 functional endoscopic sinus surgery (fess) procedure.It was reported that the axiem box had multiple ports that were not functioning.The site switched the instruments to different ports.The clinical specialist checked out the system and was able to replicate the port failures.There was a delay of less than 1 hour.No patient impact was correlated with this event.New information received: serial number is unknown: potential defective unit has already been shipped back to medtronic.

Manufacturer Narrative

Product id: 9660651; serial/lot: (b)(6); h3: the axiem was returned to the manufacturer for analysis.Functional testing determined that reported problem could not be duplicated.The axiem unit was connected to a test system with the ent application for a multi-hour burn-in test.Registration, tracking, and accuracy looked normal on all 8 tool ports.The manufacturer representative connected / disconnected the tools from each port multiple times and system remained functional.Codes associated to the axiem: fdr 213, fdc 67 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.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9853333
• MDR Text Key: 184072533
• Report Number: 1723170-2020-00960
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• PMA/PMN Number: K001284
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 91