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

Model Number 9733856

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the system was performing as intended.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 regarding a navigation system being used for a cranial biopsy.It was reported that intra-operatively, the passive planar blunt was flickering between red and green in the software.A manufacturer representative had the site replace the spheres and thought it resolved the issue, but it occurred later in the case.The procedure was completed using the navigation system and there was no reported impact to patient outcome.There was a reported delay to the procedure of less than one hour due to this issue.

Manufacturer Narrative

Other relevant device(s) are: product id:930556, serial/lot #: unknown, ubd: unknown, udi#: unknown; product id:960556, serial/lot #: unknown, ubd: unknown, udi#: unknown.The product id for the passive planar probe was reported as unknown.Both 930556 and 960556 were provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information that the site was able to use the passive planar blunt probe enough to see what they wanted to see.The site was having trouble getting the probe to track when trying to navigate.

• Brand Name: STEALTHSTATION S7 SYSTEM
• 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: 9290197
• MDR Text Key: 165438233
• Report Number: 1723170-2019-05500
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2013
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2012
• 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
• Patient Age: 83 YR
• Patient Weight: 82