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

Model Number 960-556

Device Problem Output Problem (3005)

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

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was requested, but site says it is not available.The lot number has been requested.The site has refused the return of the probe.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during a cranial biopsy.It was reported that the site had difficulty with their non-sterile passive planar probe during registration.The camera would only see the probe when it was held at a 90 degree angle.The site replaced the spheres and adjusted the lights, but these did not resolve the issue.The site made it through registration, but the probe was flickering in and out.The probe was switched out for another probe and the issue was resolved.It was determined that the top sphere was the cause of the problem.All five spheres showing geometric error of 0.84, while the top sphere's covered geometric error was 0.23.There was no patient harm and the procedure was not delayed.

Manufacturer Narrative

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

• Brand Name: BLUNT PASSIVE PLANAR 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: 9992719
• MDR Text Key: 188736744
• Report Number: 1723170-2020-01291
• 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: 05/06/2020

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
• Device Operator: Health Professional
• Device Model Number: 960-556
• Device Catalogue Number: 960-556
• Device Lot Number: 308046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 05/01/2020
• Supplement Dates FDA Received: 05/06/2020
• 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