MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NON-INASIVE PATIENT TRACKER; INSTRUMENT, STEREOTAXIC

Model Number	9734887
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device lot number, or serial number, unavailable.The instrument was not returned, so no analysis was conducted.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a tumor resection procedure.It was reported that a patient who had an mri with the stingray tracker on received a bur in shape of the tracker.The doctor reported that the burn was healing.The medtronic representative reported that the site was not following mri safety protocol and the cable was not bundled per instructions.They were able to remove all of the tumor and the patient is healing just fine.
Additional Manufacturer Narrative
Response to fda request: this submission is a copy of the response letter sent to the fda on 18-mar-2020 with regards to a fda request for additional information that provides additional information and findings related to this mdr.If information is provided in the future, a supplemental report will be issued.(b)(4).
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system functioned as designed.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a tumor resection procedure and caused no delay to the procedure.It was reported that a patient who had an mri with the stingray tracker on received a bur in shape of the tracker.The doctor reported that the burn was healing.The medtronic representative reported that the site was not following mri safety protocol and the cable was not bundled per instructions.The procedure was a tumor resection.They were able to remove all of the tumor and the patient is healing just fine.

• Brand Name: NON-INASIVE PATIENT TRACKER
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8646808
• Report Number: 1723170-2019-02714
• Device Sequence Number: 19400046
• Product Code: HAW
• UDI-Device Identifier: 00643169488113
• UDI-Public: 00643169488113
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: 9734887
• Device Catalogue Number: 9734887
• Device Lot Number: 190213F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/28/2019; 08/08/2019; 03/18/2020
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/18/2019; 08/28/2019; 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR
• Patient Weight: 89