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

Model Number S7

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

The initial report occurred on 08/25/2016 and was found to be a non-reportable malfunction based on the information available at the time the event occurred.On 01/17/2017, a retrospective review related to a capa was completed for all events where the reported malfunction was not previously associated with serious injuries; the reporting determination has been revised to consider these malfunction events reportable.Patient weight not available from the site.Device manufacturing date is unavailable.Onsite investigation was preformed, the field systems engineer discovered a loose connection to the surgeon monitor which caused the reported event.Issue was resolved when he properly tightened the connection.No further issues were reported.A full system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A site representative reported that, while in a spinal fusion procedure, the surgeon monitor screen went completely black.It did not show "no signal".They rebooted the system which resolved the issue.The monitor had not been bumped and the cable had not moved when it cut out.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.

• 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: sam saleh ; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6314549
• MDR Text Key: 67267727
• Report Number: 1723170-2017-00621
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• 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
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR