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

Model Number 9735665

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that there was no connection between the two carts. there was no patient involvement.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735772, serial/lot #: -, ubd: , udi#: ; product id: 9735845, serial/lot #: -, ubd: , udi#: ; product id: 9735815, serial/lot #: -, ubd: , udi#: ; product id: 9735821r, serial/lot #: (b)(6), ubd: , udi#: h3: a medtronic representative went to the site to test the equipment.Testing revealed that there was no connection to the camera cart.The external cable between the main cart and camera cart, internal connector on main cart and camera cart, and camera were replaced.The navigation system then passed the system checkout and was found to be fully functional.The camera was returned to the manufacturer for analysis.Analysis found that the returned positioning sensor unit (psu) had many nicks and scratches on the housing and lenses.A check of the event log showed intermittent firmware incompatibility.There was a low battery voltage message along with bump detected and storage temperature exceeded.The psu failed an accuracy test (aak) at 0.745mm with a passing threshold of 0.250mm.Analysis found that the reported event was related to an electrical issue.H6: fdm b01, fdr c13, fdc d02 are applicable to the system checkout.Fdm b01, fdr c02, c07, c08 and fdc d02 are applicable to the hardware analysis.Multiple annex g codes were reported.G02015 corresponds to the concomitant product 9735772, 9735845, and 9735815.G05001 corresponds to the concomitant product 9735821r.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19215725
• MDR Text Key: 341432253
• Report Number: 1723170-2024-01175
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

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: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2018
• 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