MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INSTRUMENT TRACKER EM ENT; INSTRUMENT, STEREOTAXIC

Model Number 9733533

Device Problems Mechanical Problem (1384); Output Problem (3005)

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

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

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).It was reported that the site had registered their patient and then they were unable to verify the straight suction.Technical services (ts) requested that they confirm the value in the software for the non-invasive patient tracker and the value was 3.4.It was recommended that any extra metal be removed from the electromagnetic (em) field.A monitor that was close to the emitter was brought back and the value dropped to around 1.2.It was also confirmed that the emitter was about a "two fist distance" away from the em field.Ts recommended they move the emitter closer.After moving the emitter closer the surgeon was still unable to verify the instrumentation and the instrument tracker was intermittently not showing up in the tracking field.A new instrument tracker was plugged in and the issue resolved.There was a procedure delay of less than one hour and no impact to the patient.

Manufacturer Narrative

H2: additional information was received and section a was updated accordingly.H3/h6: the manufacturer representative (rep) called in to state that they went in and noted that the stand was touching the magnet.The rep had the site push the stand back and everything was working as it should and the tracker they initially used was tested and was working fine.The rep stated this was likely due to user error.Codes 10, 213 and 67 reflect this.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: INSTRUMENT TRACKER EM ENT
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9616899
• MDR Text Key: 183923290
• Report Number: 1723170-2020-00216
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733533
• Device Catalogue Number: 9733533
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 70