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 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.A medtronic representative went to the site to test the navigation system.Testing revealed that the navigation system was performing as intended.The system passed the system checkout and was found to be fully functional.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 procedure.It was reported that intra-operatively, the passive planar probe was intermittently tracking.The geometry error remained between 0.3mm to 0.5mm.When the site brought in a new probe, the issue resolved.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 two minutes due to this issue.

Manufacturer Narrative

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

Event Description

Medtronic received additional information that the procedure type was tumor resection.It was reported that the cause of the reported issue was unknown; it was reported that they were trying to determine if the probe or the spheres were the issue.

Manufacturer Narrative

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

Event Description

Medtronic received additional information that the cause was unknown; the site swapped spheres, probe, and wiped off the navigation system camera to try and cover all bases.It was reported that the issue had not recurred.

• 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: 9296002
• MDR Text Key: 165762890
• Report Number: 1723170-2019-05522
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00673978090122
• UDI-Public: 00673978090122
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• 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: 308046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• 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
• Patient Age: 75 YR
• Patient Weight: 77