MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S7 SYSTEM INSTRUMENT, STEREOTAXIC

Model Number 9734056

Device Problem Mechanical Problem (1384)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site. No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used pre-operatively of a cranial anchorage procedure. It was reported the system had to abort navigation during surgery. It was noted that the original procedure was supposed to be a cranial anchorage, but had to switch to craniotomy due to navigation being aborted. This issue occurred after anesthesia has been administered, but before any incision has been made. The procedure was completed without the use of navigation. There was a less than 1-hour delay to the procedure.

Manufacturer Narrative

Analysis on the returned monitor resulted in no failure being found through functional testing and visual/physical examination. Analysis on the returned uninterruptible power supply (ups) resulted in no failure being found through functional testing and visual/physical examination. Analysis states that the ups was able to power up and run from battery power and recharge a known good battery. Analysis on the returned polaris spectra resulted in no failure being found through functional testing, visual/physical examination, and proceduralized device testing. Analysis states that the polaris spectra passed an accuracy test at. 25 mm with a passing threshold of. 35 mm. No problem found. Analysis on the returned polaris spectra system control unit (scu) resulted in no failure being found through functional testing and visual/physical examination. Analysis states that the event logs did not reveal any adverse events. No problem found. Analysis on the returned field generator resulted in no failure being found through functional testing and visual/physical examination. Analysis states that it was connected to a test system for a multi-day burn-in and it remained in green testing. Fully functional. Analysis on the returned axiem unit resulted in no failure being found through functional testing and visual/physical examination. Analysis states that it was connected to a test system for a multi-hour burn-in test. No failure found. Analysis on the returned monitor cable resulted in no failure being found through functional testing and visual/physical examination. Analysis states that the cable passed continuity test with no opens or shorts detected. Analysis on the returned axiem power/data cable resulted in no failure being found through functional testing and visual/physical examination. Analysis states that the cable passed continuity test with no opens or shorts detected. No problems found. Analysis on the returned power supply resulted in no failure being found through functional testing and visual/physical examination. Analysis states that all outputs measured in the normal range. No problems found. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: a medtronic representative tested the computer and testing determined there were no malfunctions with the computer. The system then passed the system checkout and was found to be fully functional. A second battery for the navigation system was returned to the manufacturer for analysis. The battery was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. Analysis on the returned on/off switch cable resulted in no failure being found through functional testing and visual/physical examination. There were no problem found. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional analysis.

• Brand Name: NAVIGATION STEALTH STATION S7 SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8089492
• MDR Text Key: 128042312
• Report Number: 1723170-2018-05751
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9734056
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse