MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TRACER POINTER; INSTRUMENT, STEREOTAXIC

Model Number	9735317
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No products have been returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system used pre-operatively of a functional endoscopic sinus surgery (fess).It was reported that the tracer pointer was unstable and would switch from green to red status frequently.The emitter was in a good spot for visualization of the probe.The tracker details indicated a high geometry value.Technical services (ts) advised they open a new tracker which worked right away and they were able to get a successful registration.There was a reported delay to the procedure of one hour.There was no reported impact to the patient.
Event or Problem Description
Additional information was received.It was reported that this was an out-of-box failure.
Additional Manufacturer Narrative
H2: additional information has been received.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: TRACER POINTER
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10528467
• Report Number: 1723170-2020-02431
• Device Sequence Number: 3056133
• Product Code: HAW
• UDI-Device Identifier: 00643169490024
• UDI-Public: 00643169490024
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 9735317
• Device Catalogue Number: 9735317
• Device Lot Number: 190601E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 54