MAUDE Adverse Event Report: MEDTRONIC, INC. PERCUTANEOUS LEAD INTRODUCER; INTRODUCER, CATHETER

Model Number	6209-S1
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the introducer was returned and analyzed.Analysis indicated the sheath of the lead introducer was kinked/buckled.The sheath of the lead introducer was torn.Visual analysis of the introducer indicated damage during use.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.
Event or Problem Description
It was reported that during implant, the introducer became kinked due to patient anatomy which led to insulation damage of the right ventricular (rv) lead.The introducer was changed out and the rv lead was explanted and replaced with a new lead.No patient complications have been reported as a result of this event.The introducer was returned to the manufacturer, analyzed, and tested out of specification.

• Brand Name: PERCUTANEOUS LEAD INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view,mn
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view,mn
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 23353518
• Report Number: 2182208-2025-06950
• Device Sequence Number: 9018757
• Product Code: DYB
• UDI-Device Identifier: 00763000725488
• UDI-Public: (01)00763000725488(17)270203(10)GB9603561(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K911236
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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 Model Number: 6209-S1
• Device Catalogue Number: 6209-S1
• Device Lot Number: GB9603561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 693565 LEAD.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 65 KG