MAUDE Adverse Event Report: Medtronic, Inc. Percutaneous Lead Introducer; INTRODUCER, CATHETER

Model Number	6207-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	07/16/2026
Type of Reportable Event	Malfunction

• 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--439 ; +1(763)526-9277
• MDR Report Key: 50218934
• Report Number: 2182208-2026-48811
• Device Sequence Number: 18713631
• Product Code: DYB
• UDI-Device Identifier: 00643169646155
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 6207-S1
• Device Catalogue Number: 6207-S1
• Device Lot Number: GB10101714
• 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: 07/16/2026
• Initial Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 08/11/2025
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 165 LB