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

Model Number 960-556

Device Problem Output Problem (3005)

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

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Patient weight not available.Device lot number unavailable.Udi not available.A manufacturer representative went to the site to test the navigation system.While on-site, it was discovered that the passive planar blunt had a bent post.It was still possible to register the probe using four spheres instead of five.Device manufacturing date 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 resection.It was reported that intra-operatively, the surgeon was having issues registering a patient because the non-sterile passive planar was having tracking issues.The instrument was flickering while tracking.The site switched spheres, tried a new probe, and removed and re-added the probe into the software without resolution.Technical services (ts) was contacted for troubleshooting and confirmed that there were no other instruments in view of the camera and the frame was being tracked fine.Ts recommended covering the spheres on the instrument on at a time to see if allowed the instrument to track without the issue.After doing so, the surgeon stated with one of the spheres covered, the instrument was tracking, so ts recommended removing that sphere from the post.The surgeon then re-registered with a passing metric and was able to move forward with the case.The procedure was completed using the navigation system and there was no reported impact to patient outcome.There was a reported delay to the procedure of an hour or longer due to this issue.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PASSIVE PLANAR BLUNT 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: 9434146
• MDR Text Key: 183091998
• Report Number: 1723170-2019-05902
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972398
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 960-556
• Device Catalogue Number: 960-556
• Device Lot Number: 180404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2018
• 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: 71 YR
• Patient Weight: 84