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

Model Number 9735665

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/22/2021

Event Type  Injury  

Manufacturer Narrative

The neuro accessory kit was returned to the manufacturer for analysis.The kit was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.Other relevant device(s) are: product id: 29631, serial/lot #: (b)(4), udi#: (b)(4); product id: 9735571, serial/lot #: unk.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system and automated trajectory guidance unit being used during a catheter placement for a medtronic thermal therapy system procedure.It was reported that there were difficulties placing the bone anchor.It was reported that after alignment with the guidance unit and drilling a burr hole, the bone anchor was not "smooth".It was noted that there were difficulties with alignment of the guidance unit as well.A second burr hole was attempted, but it was noted that the hole was overburred.It was reported that the drape around the guidance unit did not interfere with the guidance unit and that the unit pressed against the mayfield in the room.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.

• Brand Name: STEALTHSTATION S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12624377
• MDR Text Key: 276166481
• Report Number: 1723170-2021-02493
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 71