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

Model Number S7

Device Problems Unstable (1667); Communication or Transmission Problem (2896)

Patient Problems Therapeutic Response, Decreased (2271); Iatrogenic Source (2498)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

Patient information was not made available from the site, this hospital refused requests for patient demographic information. On 07/15/2016 a medtronic representative reported while in the optical cranial biopsy program, the magnetic resonance imaging (mri) was thresholded by the stealth nurse in the room, and the patient was registered. During the biopsy, the surgeon placed a navigus probe into the glass tube, the entry was set, the foot-pedal button was pressed and the typical audible beep was heard, however, the program did not auto forward to a lock trajectory window. Since the surgeon could not lock trajectory when putting the biopsy needle in the reducing tube, it would not recognize it. Attempted to use a new biopsy needle, re-booted the navigation system and the software application, however, this did not resolve the issue. Re-registering the patient on a second navigation system also did not improve results. The surgeon opted to re-schedule the procedure. On 07/15/2016 a medtronic representative performed a navigation system check-out, all areas passed. System performed as intended. On 07/29/2016 a medtronic representative, following-up at the site, reported the second procedure was successful, the same burr hole was used. Although the site refused to provide patient demographic information, it was noted that this patient was not obese. No parts were replaced. No parts have been received by manufacturer for analysis. No further issues have been reported.

Event Description

A medtronic representative reported that, while in a cranial biopsy procedure, the surgeon inserted the navigus probe into the guide stem, however, the views did not switch to guidance view automatically and locking trajectory was not an option. In trouble-shooting, it was discovered that custom procedures were created and labeled "optical biopsy" however, they were not created from the "biopsy" procedure so the functionality was not available as an option. Delay in therapy was greater than one hour, at this point, the surgeon opted to halt the procedure and re-schedule. Per a medtronic representative attending the procedure, the navigation system was fully functional.

Manufacturer Narrative

A medtronic representative reported that the patient was an older female. The delay to the surgery was 1. 5 to 2 hours. The site would not share any other information. Correction: the investigation found that the issue was caused by user technique and there was no product problem. The software investigation found that the reported event was unrelated to a software issue. Per the reported event, it was discovered that custom procedures were created, labeled "optical biopsy" but were not created from the "biopsy" procedure so the functionality was not available. The software functioned as designed.

• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5855567
• MDR Text Key: 51454760
• Report Number: 1723170-2016-02056
• Device Sequence Number: 1
• Product Code: HAW
• 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
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 08/08/2016 Patient Sequence Number: 1