MAUDE Adverse Event Report: MEDTRONIC NAVIGATION INC STYLET 9735428 2 COIL SINGLE PACAKGE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9735428
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used during a catheter placement procedure.It was reported that registration and navigation went smoothly.In the post operative computed tomography (ct)control it was noticed that the drainage had not been placed at the planned target.The site had to do a reintervention, but had to use a passive catheter introducer (pci) tip.The procedure was completed successfully the second time.There was an inaccuracy of 4mm, the direction of inaccuracy was not specified.Inaccuracy occurred during navigation and was isolated to just the stylet instrument.There was no surgical delay.There was no impact on patient outcome.
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id: 9735428, lot #: 230516a, ubd:- , udi#:- h3, h6: no products have been returned to medtronic for analysis.Codes b18, c20, and d15 are applicable.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: STYLET 9735428 2 COIL SINGLE PACAKGE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION INC; boxborough
• Manufacturer (Section G): MEDTRONIC NAVIGATION INC; boxborough
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20558926
• Report Number: 1723170-2024-03347
• Device Sequence Number: 8866133
• Product Code: HAW
• UDI-Device Identifier: 00763000588489
• UDI-Public: 00763000588489
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2025
• Device Model Number: 9735428
• Device Catalogue Number: 9735428
• Device Lot Number: 230516A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose