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

Model Number 9733856

Device Problems Data Problem (3196); Intermittent Communication Failure (4038)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as there was no patient involved in this event.A medtronic representative tested the data set over the phone.Testing revealed that the system was working as intended.The ct was used as the reference and was merged with the other data sets.On the registration screen the ct was still the registration exam.The system passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from the manufacturer representative regarding a navigation device being used outside of procedure.It was reported that the patient was not yet present in the room.Site merged ct with 4 mri's.The correct model appeared in planning.However, when they changed to registration, the incorrect model (mri) appeared selected on the screen and the exam selected as the "select exam" value was set to the mri.The manufacturer representative was able to change it to the ct but was not sure why the incorrect exam was selected as reference.There was no patient involved in the event.

• Brand Name: 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: 8566646
• MDR Text Key: 143697021
• Report Number: 1723170-2019-02064
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2019

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: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2013
• 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