MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC AXIEM TRACER POINTER PROBE; INSTRUMENT, STEREOTAXIC

Model Number	9733367
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tracer pointer probe was returned to medtronic for analysis.Analysis was able to duplicate the reported issue.It was found that the returned pointer would not track when connected to a known good system.A check of the em interface showed that coils #1 and #2 were dead, and that only coil #3 was functioning.Please reference mdr 1723170-2018-05428 for the stealthstation s7 system involved in this event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a catheter placement procedure.It was reported the tracer probe stopped tracking intraoperatively.The tracer probe was reportedly damaged.The site had successfully registered the patient, then began moving the patient¿s head to begin surgery.The medtronic representative (rep) on site noticed movement in the patient reference frame while the site was moving the patient¿s head.The rep had the site check accuracy, and they were no longer accurate.The site switched patient trackers and began doing another registration.While registering the second time, the tracer probe was not tracking.The port on the axiem box was green; the rep moved the emitter and could not get the probe to track.The tracer probe was replaced, and the new probe successfully tracked.The site was able to register and continue the case.There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.

• Brand Name: AXIEM TRACER POINTER PROBE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8026583
• Report Number: 1723170-2018-05429
• Device Sequence Number: 11114518
• Product Code: HAW
• UDI-Device Identifier: 00613994333780
• UDI-Public: 00613994333780
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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 Expiration Date: 09/29/2017
• Device Model Number: 9733367
• Device Catalogue Number: 9733367
• Device Lot Number: 150930A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 76