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

Model Number 9733858

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

Foreign report source: (b)(6).A medtronic representative visited the site to evaluate the equipment.The rep replaced the psu, at which point the system ran successfully.The returned psu powered up without the amber fault light on but it came on during testing.A check of the event log showed an intermittent history of illuminator current low.The rep was not able to perform an accuracy test (aak) due to the hardware fault.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 the psu could not recognize the passive tools.There was no patient present.Additional information was received.It was reported that only active tools could be verified.The cause has been identified as the psu failing.

• 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: 10005890
• MDR Text Key: 189340376
• Report Number: 1723170-2020-01315
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169505742
• UDI-Public: 00643169505742
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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
• Date Manufacturer Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• 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