MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CRANIAL REFERENCE FRAME, SMALL PASSIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 961-337

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2024

Event Type  malfunction  

Manufacturer Narrative

H3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.Multiple fdd/annex a codes were reported.A0709 was coded for the top right sphere showing red on the navigation system and flickering camera.A0908 was coded for the inaccuracy and being off by several millimeters.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 Description

Medtronic received information regarding a navigation system being used during a cranial resection procedure.It was reported that there were issues with the reference frame early on in the procedure.The top right sphere was showing red on the navigation system, but the probe and images were accurate.About halfway through, the frame on the camera would flicker for a fraction of a second and disappear unless the surgical team covered the offending sphere. navigation was used periodically through the case to verify where they were in the brain. once they covered the sphere, it could be visualized and deemed to be accurate.Near the end of the case, they checked again and it was noticed that the images were off by several millimeters.The probe was inside of the skull, but the navigation system monitor was showing the tip above the scalp.The spheres were cleaned and the offending sphere was replaced, but the result was the same.The surgeon, while noting that this was not reassuring, felt comfortable at that point to finish the procedure without the use of navigation.There was no reported delay to the procedure due to this issue.There was no reported impact on pati ent outcome.Additional information was later received.It was assumed that the issue was related to hardware, perhaps a bent pin.It seemed unlikely that the entire frame was bent or warped, and less likely to be software-related.After speaking with other manufacturer representatives, it was reported that the reference frame moving seemed to be the most likely scenario and the only one that makes sense to cause the reported event.The surgical team was working a lot around the frame, but it seemed most likely that it got moved while replacing the offending sphere.It was difficult to remove, and perhaps when they were pushing the spheres down it could have moved.

• Brand Name: CRANIAL REFERENCE FRAME, SMALL PASSIVE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19174335
• MDR Text Key: 341285424
• Report Number: 1723170-2024-01138
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 961-337
• Device Catalogue Number: 961-337
• Device Lot Number: 231012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1