MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. ZEISS KINEVO INTERFACE KIT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9736149
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: no products have been returned to medtronic and a system checkout has not been performed.Codes b20, c20, and d15 are applicable to this analysis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a navigation system being used in an unknown procedure.It was reported that the system did not recognize all of the dogbone light emitting diodes (leds) on the microscope while it was draped, or undraped.It was noted that the manufacturer representative (rep) reconnected the tracker multiple times without resolution.It was reported that the bracket was undraped and still was intermittently flickering.It showed flickering from the front of the tracker, but not from the sides.There was no impact on patient outcome.It was reported that the issue occurred intra-operatively.There was no surgical delay.It was reported that the issue occurred during a cranial resection procedure.

• Brand Name: ZEISS KINEVO INTERFACE KIT
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 25089900
• Report Number: 1723170-2026-00701
• Device Sequence Number: 9991087
• Product Code: HAW
• UDI-Device Identifier: 00763000244774
• UDI-Public: (01)00763000244774(11)190716(10)0009830500
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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 Model Number: 9736149
• Device Catalogue Number: 9736149
• Device Lot Number: 0009830500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 91 KG