MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STYLET 9735428 2 COIL SINGLE PACKAGE; INSTRUMENT, STEREOTAXIC

Model Number	9735428
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier not available from the site.Device lot number, or serial number, unavailable.The instrument was discarded, so no analysis was conducted.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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 a catheter placement procedure.The issue occurred intraoperatively and caused no delay to the surgery.It was reported that there was no problem till registration.The operative field became sterile and when the stylet got close to the sterile operative field, the recognition was unstable.Adjusting the position of metal and emitter was performed, but no improvement was seen.The procedure was completed with the continuous use of the navigation system and there was no impact on patient outcome.

• Brand Name: STYLET 9735428 2 COIL SINGLE PACKAGE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8495824
• Report Number: 1723170-2019-01623
• Device Sequence Number: 1780510
• Product Code: HAW
• UDI-Device Identifier: 00643169490468
• UDI-Public: 00643169490468
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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 Model Number: 9735428
• Device Catalogue Number: 9735428
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1