MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PATIENT TRACKER 9734887XOM NON-INVASIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9734887XOM
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the onsite inspection the medtronic representative found that the wire on the patient tracker was tied in a knot and damaged with the wires exposed.The rep replaced the part.The replaced part has not been received by the manufacturer for further analysis.A successful system checkout was performed which verified that the issue had been resolved.
Event or Problem Description
A medtronic representative reported that during a catheter placement procedure the site registered the patient, but when they moved toward the navigate screen the patient tracker was not visible in the tracking view, but a stylet was visible when they brought it in the field of view.The case continued without navigation.There was no patient impact reported and the delay in surgery was less than an hour.Surgery proceeded as planned.

• Brand Name: PATIENT TRACKER 9734887XOM NON-INVASIVE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7228631
• Report Number: 1723170-2018-00459
• Device Sequence Number: 16436485
• Product Code: HAW
• UDI-Device Identifier: 00643169488120
• UDI-Public: 00643169488120
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/30/2018

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 Catalogue Number: 9734887XOM
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 78