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

Model Number	9735428
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hardware analysis of the three returned stylets found they were recognized by a known good system, but would not track.The stylets returned a red status.All three stylets had tape around their shaft upon return.A check of the electromagnetic interface showed that all three coils were dead on two of the stylets.The other stylet had an active coil.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used intra-operatively of a catheter placement procedure.It was reported that they could not see the stylets.They used one stylet that didn't detect at all.They opened a second stylet which detected for 3 passes, then picking it up again, it no longer detected.They opened a third stylet that detected for 3 passes then stopped detecting.The issue extended the surgical time by less than one hour.There was no impact on the patient outcome.The surgery was completed with the use of a c-arm.The tracking issue was thought to be related to the stylets as the system never lost the patient tracker and the stylet was green on the instrument screen, which indicated it was plugged into the emitter.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system functioned as designed.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the navigation system used alongside the instrumentation was used in multiple procedures without issue since the event date.

• 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: 9282248
• Report Number: 1723170-2019-05480
• Device Sequence Number: 11434182
• Product Code: HAW
• UDI-Device Identifier: 00643169490468
• UDI-Public: 00643169490468
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2020

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 Expiration Date: 03/15/2021
• Device Model Number: 9735428
• Device Catalogue Number: 9735428
• Device Lot Number: 190316C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/13/2019; 01/24/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/10/2019; 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR