MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC Stealthstation® S7¿ INSTRUMENT, STEREOTAXIC

Model Number 9733856

Device Problems Material Integrity Problem (2978); Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. Testing revealed that after the cable was replaced, the issue was resolved. The system then passed the system checkout and was found to be fully functional. The power cable was returned to the manufacturer for analysis. Analysis found that the ground prong was broken off and was missing. Analysis found that the reported event was related to a mechanical issue. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system. It was reported outside of a procedure that the system had a missing ground prong. No patient was present.

• Brand Name: Stealthstation® S7¿
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: 8455330
• MDR Text Key: 139971817
• Report Number: 1723170-2019-01373
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/13/2013
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse