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

Model Number 9733858

Device Problems Environmental Compatibility Problem (2929); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Other relevant device(s) are: product id: 9735225r, serial/lot #: (b)(4).Report source foreign country: (b)(6).The manufacturer representative went to the site to test the navigation system.The reported issue was confirmed and parts were replaced.The manufacture date was not available at the time of reporting.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 computer does not switch on from time to time.No patient was present at the time of the event.Additional information was received stating that the issue occurred only once and that the computer was slow and the images freeze.

Manufacturer Narrative

The computer was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The computer boots normally to the application screen.The computer booted normally multiple times during burn-in testing.The installed programs start and run normally.They found 4 bad sectors and 4 un-correctable sectors.A bad computer was observed.If information is provided in the future, a supplemental report will be issued.

• 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: 9445565
• MDR Text Key: 183521624
• Report Number: 1723170-2019-05936
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

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: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/16/2020
• 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: Reuse
• Patient Sequence Number: 1