MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Self-Activation or Keying (1557); Sticking (1597); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.Return requested for ext sc to r/a psu cable.No parts have been received by manufacturer for analysis.On 12/30/2015 a medtronic representative, following-up at the site to trouble-shoot, re-seated the camera cable at the base of the staff cart and upon entering the software, the camera was communicating properly.The medtronic representative re-booted the navigation system several times, performed multiple registrations, and left the navigation system on for an hour, however, the reported issue could not be replicated.The medtronic representative inspected the camera cable within the arm and did not find any damage.On 01/15/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.

Event Description

A site registered nurse (rn) reported that, while in a procedure, the navigation system camera would intermittently cycle.The camera would track normally and then stop tracking and the screen would display localizer not connected.The camera would then beep three times and a few seconds after the beeps the camera would start to track again.This continued to occur every few minutes.Re-starting the navigation system did not resolve the issue.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.

Manufacturer Narrative

The hardware investigation found that the reported event was related to a hardware issue.Examination of the returned cable found bent and missing pins in the lemo connector that connects to the internal positioning sensor unit (psu) cable at the bottom of the cart.Do to the damaged pins, it was not possible to connect the lemo connectors together.This issue was documented in a medtronic navigation hardware anomaly tracking database.(b)(4).

Manufacturer Narrative

A medtronic representative reported that he was not able to replicate the issue.The camera was navigating and working fine after navigating for almost an hour.He went ahead as a precaution and replaced the io hub, io comm cables and psu comm cables.He then checked the navigation system after replacing each component individually and still could not replicate the camera cycling issue.Replacing all the components appears to have resolved the issue.The rep will monitor the issue moving forward.The positioning sensor unit (psu) was returned for analysis.When connected to a known good system the psu had difficulty tracking in the middle and back of the volume.There were no messages of "localizer not connected" found as described in the reported event.The psu did not pass the accuracy test.The hardware investigation found that this issue was unrelated to the reported event.This issue was documented separately in a medtronic navigation hardware anomaly tracking database.

Manufacturer Narrative

The following hardware components were returned to the manufacturer for analysis: i/o hub was set up on our bench tester with scu-i/o hub cable and usb cable that were returned for this case.This configuration was tested for ~24 hours without any issues.No fault found.Usb cable continuity was tested and there are no opens or shorts.Cable was set up on our bench tester with i/o hub and scu-i/o hub cable that were returned for this case.This configuration was tested for ~24 hours without any issues.No fault found.The returned scu to r/a psu cable was found to be in good condition and passed a continuity test with no opens or shorts detected.No problem found.Tested scu to i/o hub cable continuity and there are no opens or shorts.Cable was set up on our bench tester with i/o hub and usb cable that were returned for this case.This configuration was tested for ~24 hours without any issues.No fault found.Initial evaluation of the computer found that it was returned unused however packaging had been opened requiring further testing.Currently under analysis.No problems were found with the returned components.As previously reported the issue was resolved by replacing the positioning sensor unit (psu).

Manufacturer Narrative

The computer was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5385408
• MDR Text Key: 37013539
• Report Number: 1723170-2016-00094
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1