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

Model Number S7

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been received by the manufacture for evaluation.

Event Description

A medtronic representative reported that while testing, the camera of the navigation system was restarting intermittently.There was no patient present at the time of the issue.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that the camera and tiu of the navigation system were replaced without resolution.The representative returned to the site and replaced the computer for the navigation system.On a third visit, as the reported issue persisted, the tiu and associated cables were replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts have been received by the manufacturer for evaluation.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that the positioning sensor unit (psu) and in/out hub of the navigation system were replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Manufacturer Narrative

The positioning sensor unit (psu) and polaris spectra system control unit (scu) has been by the manufacturer for evaluation.The positioning sensor unit (psu) had many nicks and scratches.When connected to a known good system the returned positioning sensor unit (psu) did not cycle as was reported.A check of the event logs did not reveal any issues.However, it failed the accuracy test.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.The returned polaris spectra system control unit (scu) was connected to a known good system and was found to be fully function.A check of the logs did not reveal any issues.

Manufacturer Narrative

Two polaris spectra system control unit (scu) to positioning sensor unit (psu) communication cables were returned to the manufacturer for analysis.The devices were found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The polaris spectra system control unit (scu) 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.

Manufacturer Narrative

The io hub and the positioning sensor unit (psu) for the navigation system were returned to the manufacturer for analysis.The devices were 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7169705
• MDR Text Key: 96990620
• Report Number: 1723170-2018-00085
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2010
• 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