MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OSTIUM SEEKER, AXIEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733448
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No part returned for analysis.
Event or Problem Description
Medtronic received information regarding a navigation system outside of a procedure.It was reported that the seeker was damaged.There was no patient present.
Additional Manufacturer Narrative
Additional information:lot number and manufacture date provided.Correction: unique device identification(udi) updated to proper value.
Additional Manufacturer Narrative
The ostium seeker was returned to the manufacturer for analysis.Analysis found that the seeker was in good condition with no physical damage.The seeker verified and operated successfully.No failure found with device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: OSTIUM SEEKER, AXIEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7674246
• Report Number: 1723170-2018-03271
• Device Sequence Number: 10924065
• Product Code: HAW
• UDI-Device Identifier: 00643169702820
• UDI-Public: 00643169702820
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2019

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 Catalogue Number: 9733448
• Device Lot Number: 18011723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 07/20/2018; 03/28/2019
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/07/2018; 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1