MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7; INSTRUMENT, STEREOTAXIC

Model Number 9733858

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9733571, serial/lot #: (b)(4), udi#: (b)(4).Analysis of the 9733858 found the connection cabling/hardware was damaged.Analysis of the 9733571 found the connection cabling/hardware was damaged.A continuity test revealed an open from pin 10 of the hd26 connector to pin 16 of the fischer connector.This was the audio right signal.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system while outside of procedure.It was reported that there was an issue with the surgeon monitor external cable.It was stated that when the pressure was applied to the cable, an interference noise can be heard on the system speakers and was repeatable.There was no patient present when the issue occurred.

• 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: 8669316
• MDR Text Key: 151159638
• Report Number: 1723170-2019-02961
• 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: Other
• Type of Report: Initial
• Report Date: 06/04/2019

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: Health Professional
• Device Model Number: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1