MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735669

Device Problems Device Sensing Problem (2917); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

Onsite functional and visual examination was performed by a manufacturer representative.The emitter was replaced and the issue was resolved.The system passed a system checkout and was returned to an operational condition.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).It was reported that the site's break out box (bob) port 3 and 5 have a loose connection and are intermittent with nipt tracking.The nipt consistently tracks if the plug in portion is held in place, once they let go the navigation is in and out with those two ports only.Different nipt were used with same results.Surgery continued with nipt in other ports.There was no reported delay and no reported impact on patient outcome.

• Brand Name: STEALTHSTATION S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11913122
• MDR Text Key: 253696813
• Report Number: 1723170-2021-01444
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169838918
• UDI-Public: 00643169838918
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• 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
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2019
• 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: 75 YR
• Patient Weight: 97