MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. PASSIVE PLANAR BLUNT PROBE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	960-556
Medical Device Problem Codes	No Device Output (1435); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 outside of a procedure.It was reported that the probe was only showing correctly when it was turned directly towards the camera, any slight movement caused blinking of the instrument on the navigation screen.It could be verified, but registration could not be done with it, since it blinked all the time.The site checked the balls, then changed them and checked again if they were clean and attached correctly.After a while they brought another probe that they had, and it worked perfectly.The site said it had already happened once before with this particular probe, the exact same situation. there was no patient involvement.
Additional Manufacturer Narrative
H2) please see section d1, d4 and d5 for additional information.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.
Additional Manufacturer Narrative
H2-3) the instrument was returned to the manufacturer for evaluation.After functional testing and visual/physical examination, the reported issue was not confirmed.The results of the analysis concluded that no failure was found.Codes: b01, c19, d14 h2) please see section d9 for when the instrument was returned for analysis.H2) please see section d3.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.

• Brand Name: PASSIVE PLANAR BLUNT PROBE
• 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: 21364545
• Report Number: 1723170-2025-00635
• Device Sequence Number: 12874552
• Product Code: HAW
• UDI-Device Identifier: 00763000055387
• UDI-Public: 00763000055387
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K972398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2025

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: 960-556
• Device Catalogue Number: 960-556
• Device Lot Number: 221206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 02/17/2025; 07/22/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 02/18/2025; 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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 Sex: Unknown