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

Model Number S7

Device Problems No Display/Image (1183); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that the monitor of the navigation system was replaced to resolve the reported issue.The monitor for the navigation system 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 site representative reported that, while in a spinal fusion, the monitor of the navigation system intermittently lost display functionality.It was reported that adjustment of the power cable would temporarily restore functionality.A second monitor from a second medtronic navigation system was brought into the operating room (or) to complete the procedure.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.No additional information was provided.

Manufacturer Narrative

Correction: device manufacture date updated to proper value.

• 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: 7339049
• MDR Text Key: 102400097
• Report Number: 1723170-2018-01128
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

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: 9733856
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 03/21/2018
• Supplement Dates FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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
• Patient Age: 61 YR
• Patient Weight: 77