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

Model Number	960-556
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9296002
• Report Number: 1723170-2019-05522
• Device Sequence Number: 16847112
• Product Code: HAW
• UDI-Device Identifier: 00673978090122
• UDI-Public: 00673978090122
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K972398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: 960-556
• Device Catalogue Number: 960-556
• Device Lot Number: 308046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/08/2019; 11/27/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 11/27/2019; 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 77