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 Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Patient age not available from the site. Patient weight not available from the site. A medtronic representative went to the site to test the equipment. The representative reported that the polaris spectra system control unit (scu) to positioning sensor unit (psu) cable was replaced. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The scu to psu cable 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.

Event Description

A medtronic representative reported that, while in a spinal fusion, the camera of the navigation system lost functionality. After manual manipulation of the camera cable, functionality was restored. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no impact on patient outcome. No additional information was provided.

Manufacturer Narrative

Additional information: patient age and weight provided.

Manufacturer Narrative

Patient identifier field not sufficient to hold all digits, should read: (b)(6).

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7110019
• Report Number: 1723170-2017-05072
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Weight: 76