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

Model Number	9733879
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information will not be provided due to (b)(6) confidentiality laws: the initial reporter's name will not be provided due to (b)(6) confidentiality laws: the probe is pending return from (b)(6) for product analysis.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 during a tumorectomy.It was reported that a probe had recognition failure.Another probe was used.It was noted that the suspected cause was due to deterioration of the probe.There was no patient harm and the procedure was not delayed.
Additional Manufacturer Narrative
The probe was returned to medtronic for analysis.Testing was conducted and the issue was unable to be reproduced.There were no failures found.Fdm, fdr, and fdc codes are applicable to the probe analysis.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: 10637792
• Report Number: 1723170-2020-02623
• Device Sequence Number: 3054673
• 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
• Report Date (Section B): 11/13/2020

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
• 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: 11/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1