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

Model Number 9733856

Device Problems Operating System Becomes Nonfunctional (2996); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: cmptr 9735225r rollingstone s7 refurb.No devices have been evaluated at the time of submitting this report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used outside of a procedure.It was reported that the system was freezing up.The issue was able to be replicated during testing of the system and confirmed it occurs at various times including boot up and within the software.The video also got distorted.It was reported that the probable cause was due to the computer.There was no patient present at the time of the event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information that the cause of the issue was unknown.

• 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: 9930718
• MDR Text Key: 186751125
• Report Number: 1723170-2020-01165
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

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 Expiration Date: 11/28/2012
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2012
• 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