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

Model Number S7

Device Problems Electrical /Electronic Property Problem (1198); Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.

Event Description

A site representative reported that, while outside of a procedure, the camera of the navigation system was cycling power intermittently.Visible damage to the polaris spectra system control unit (scu) to camera cable was noted.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the representative reported that the polaris spectra system control unit (scu), positioning sensor unit (psu) and communication cable for the psu to scu were replaced to restore functionality.The system then passed the system checkout and was found to be fully functional.No parts have been received by the manufacturer for evaluation.

Manufacturer Narrative

The positioning sensor unit (psu), psu to polaris spectra system control unit (scu) cable and scu were returned to the manufacturer for analysis.The components were found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The cable for the internal breakout box of the navigation system was returned to the manufacturer for evaluation.Testing found an open in the box resulting in the footswitch not operating as designed.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.

• 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
• MDR Report Key: 7401157
• MDR Text Key: 104563255
• Report Number: 1723170-2018-01467
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2018

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
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 03/19/2018; 05/16/2018
• Supplement Dates FDA Received: 04/17/2018; 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2013
• 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