MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC LINEAR BLUNT PROBE HC; INSTRUMENT, STEREOTAXIC

Model Number	9733879
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available.Lot number not available on the date of filing.No device/components have been returned to the manufacturer on the date of filing.Manufacture date not available on the date of filing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a probe being used with a navigation system.It was reported that intra/peri-operatively during a cranial resection procedure, one led light of the long cable had recognition failure.The procedure was performed using another active probe.There was no delay to the procedure.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
Review of this event and additional information received shows that there is no evidence to reasonably suggest that the device in this report or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received regarding this event.The instrument had one led that was not functioning, the instrument had no other failure.
Additional Manufacturer Narrative
The instrument was returned to the manufacturer for analysis.Through functional testing and visual/physical examination the issue could not be confirmed or replicated.When connected to a known good system the returned probe had good geometry and divot error readings with all leds firing.There was no problem found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LINEAR BLUNT PROBE HC
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8222779
• Report Number: 1723170-2019-00117
• Device Sequence Number: 16212355
• Product Code: HAW
• UDI-Device Identifier: 00763000053536
• UDI-Public: 00763000053536
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2019

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: 9733879
• Device Catalogue Number: 9733879
• Device Lot Number: 180116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/17/2019; 02/18/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/13/2019; 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1