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

Model Number S7

Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier field not sufficient to hold all digits, should read: (b)(6).On (b)(6) 2016 a medtronic representative, following-up at the site, reported found that the site had the camera too close to the imaging system tracker.The medtronic representative was able to track the imaging system tracker on both sides with no further issues.On (b)(6) 2016 a medtronic representative performed an imaging system check-out, all areas passed.Tested trackers on both sides and both were visible.System performed as intended.Reported issue could not be replicated.No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative received a report from a site radiographic technologist (rt), that while in a spine procedure, their imaging system tracker was not visible in the navigation system tracking view.Patient reference frame was visible.Adjusting the navigation system camera did not resolve the issue.The medtronic representative recommended the site re-boot their imaging system, however, the surgeon opted to abandon the use of the imaging system and navigation system and continued the surgery to completion using a c-arm.The medtronic representative was unable to confirm with the site navigation system operator if an imaging system procedure was properly selected and the tracker was in the instrument list at that time.Delay in therapy was approximately 15-20 minutes.There was no impact on patient outcome.

Manufacturer Narrative

Patient weight now provided.

Manufacturer Narrative

Correction: see patient date of birth.

• 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: oksana ditolla ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 6145577
• MDR Text Key: 61452801
• Report Number: 1723170-2016-05629
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• 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?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2015
• 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
• Treatment: (B)(4)
• Patient Age: 47 YR
• Patient Weight: 97