MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Output Problem (3005)

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

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable.Concomitant medical products: product id: 29631, serial/lot #: (b)(4).No system checkout was performed as the resolution was confirmed on the call.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system and an automated trajectory guidance unit being used for a cranial biopsy.It was reported that intra-operatively, the surgeon experienced difficulty setting up and targeting with the automated trajectory guidance unit.It was reported that they were having issues getting the unit to the correct height for the bone thickness, as well as having issues with movement while drilling.During troubleshooting, it was found that they not tap in the drill guide.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.

• Brand Name: STEALTHSTATION S8 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10690974
• MDR Text Key: 214602869
• Report Number: 1723170-2020-02725
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000272739
• UDI-Public: 00763000272739
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Device Lot Number: N29960899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/12/2020
• 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