MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 SYSTEM; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9733856

Device Problem Imprecision (1307)

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

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

A manufacturer representative went to the site to test the equipment.During testing the reported issue was unable to be replicated.The system passed the system checkout and was found to be fully functional.No parts were replaced.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 transsphenoidal procedure.It was reported that during the case, the surgeons alleged that there was an inaccuracy of about 2 millimeters.The site registered the patient, draped the patient, had the ear, nose & throat (ent) surgeon open a path in the sinuses, and then the neurosurgeon came in to resect the tumor.The tumor in this case was a very small pituitary tumor.The ent surgeon did not actively use navigation but did check accuracy during the procedure and noticed about a 2-millimeter inaccuracy from the beginning of the case.This was also observed by the neurosurgeon.The site proceeded with the case by accounting for the inaccuracy.There was no surgical delay due to this issue, and there was no impact on patient outcome.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: EAR, NOSE AND THROAT 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8136225
• MDR Text Key: 129461062
• Report Number: 1723170-2018-06084
• Device Sequence Number: 1
• Product Code: PGW
• 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
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2013
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2012
• 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: 57 YR
• Patient Weight: 64