MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC N/A; 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	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Onsite analysis of the system was not performed as the instrument was replaced which resolved the issue.The instrument was returned and while no damage could be seen visually, when connected to a known good system, it did not turn on.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 an unknown procedure.It was reported that the cable was fractured.The procedure was completed with the use of another cable.There was no reported impact on the patient¿s outcome.There was also no reported delay to the procedure due to his event.

• Brand Name: N/A
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; lousiville CO 80027
• MDR Report Key: 7996752
• Report Number: 1723170-2018-05306
• Device Sequence Number: 427720
• Product Code: HAW
• UDI-Device Identifier: 00613994480613
• UDI-Public: 00613994480613
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

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 Model Number: 9733879
• Device Catalogue Number: 9733879
• Device Lot Number: 160115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1