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

Model Number S7

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Erratic or Intermittent Display (1182)

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

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Udi not available for this system at time of filing.Device manufacturing date is unavailable.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.The event occurred intraoperatively during the navigate task and caused minimal delay to surgical time.It was reported that while navigating, the surgeon verified the straight probe and a blue screen appeared.The manufacturer representative (mr) restarted the system and the issue was resolved.The mr also re-verified the probe and the issue was resolved.Navigation and imaging were not aborted.The surgery was completed and there was no impact on patient outcome.

Manufacturer Narrative

Device manufacturing date was updated.

• 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: sarah olhoft ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7544904
• MDR Text Key: 109280597
• Report Number: 1723170-2018-02289
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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: 05/01/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 06/06/2018
• Supplement Dates FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• 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