MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SMALL PASSIVE REFERENCE FRAME; INSTRUMENT, STEREOTAXIC

Model Number 961-337

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that while setting up for a case, the frame was going in and out of view.The geometry error was sitting between 0.4 and 0.5.Another frame was used for the upcoming case.There was no patient involved when this issue was discovered.

Manufacturer Narrative

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

Event Description

Additional information: the representative went to the site but was unable to replicate the issue.

• Brand Name: SMALL PASSIVE REFERENCE FRAME
• 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: 9921034
• MDR Text Key: 186334028
• Report Number: 1723170-2020-01150
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

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 Model Number: 961-337
• Device Catalogue Number: 961-337
• Device Lot Number: 180125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2018
• 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