MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. OSTIUM SEEKER; INSTRUMENT, STEREOTAXIC

Model Number	9733448
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.Device manufacture date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while performing a planned maintenance (pm), the ostium seeker was reported to be bent and returning a divot error between 2 to 2.6 in the application software of the navigation system.There was no patient present when this issue was identified.No additional information was provided.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.It was reported that the issue could not be confirmed or replicated.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

• Brand Name: OSTIUM SEEKER
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7990580
• Report Number: 1723170-2018-05275
• Device Sequence Number: 19275958
• Product Code: HAW
• UDI-Device Identifier: 00613994378484
• UDI-Public: 00613994378484
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 9733448
• Device Catalogue Number: 9733448
• Device Lot Number: 16098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1