MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC VERTEK PROBE; INSTRUMENT, STEREOTAXIC

Model Number 9733158

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Device lot number and unique device identifier (udi) is unavailable.The vertek probe instrument was not returned to the manufacturer for analysis.However, a system checkout performed and found to be functioning as designed.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a cranial biopsy procedure.It was reported that there was unusual behavior from the probe.It was noted that during the case the site was able to see the reference frame, but the probe was intermittently being recognized by the camera.The site checked the environment for field of view interference and moved the lights out of the way, but this did not resolve the behavior.It was noted that when a sphere was removed the intermittent behavior was resolved, but the site only wanted to continue with all 4 spheres and green status.When the site moved the probe 4 ft away from the patient the camera was able to see the probe without issue.The site was recommended to make sure the spheres were clean and the reference frame was on the opposite side of the probe.When using the probe with an aiming device and trajectory locked, the error to target changed from around 0.6 mm to about 3 mm when the probe rotated in the channel.There was no surgical delay and no impact on the patient outcome.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERTEK PROBE
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9316335
• MDR Text Key: 173051171
• Report Number: 1723170-2019-05597
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733158
• Device Catalogue Number: 9733158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 13 YR
• Patient Weight: 45