MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION C320LBB DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	C320LBBS45
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 procedure when the physician was preparing to slit and went through the hub, the catheter broke where the shaft meets the hub.The catheter was replaced. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the delivery catheter was returned and analyzed.The septum detached from the hub of the delivery catheter.The mechanical operation of the catheter shaft was kinked/buckled.The catheter shaft was torn.The shaft of the delivery catheter was spiral slit.The peel ing/slitting/splitting was not slit on the center of hub of the delivery catheter.The shaft on the hub of the delivery catheter was spiral slit.The septum adhesive released of the hub of the delivery catheter.The septum of the catheter was missing.The analyst noted the delivery catheter was returned in three pieces with the dilator.The slitter was not returned.The septum of the delivery catheter was detached and missing.There was adhesive bond within the hub of the delivery catheter.Slitting did not start on the centerline on the hub of the delivery catheter.The shaft of the delivery catheter was torn off at 6.5 cm with tear marks proximal to that area.Slitting had terminated and restarted at 13 cm.The shaft of the delivery catheter was kink/buckled at 20.3 cm and 30.2 cm.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: C320LBB DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis,mn
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis,mn
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 24938449
• Report Number: 2182207-2026-01044
• Device Sequence Number: 10670982
• Product Code: DQY
• UDI-Device Identifier: 00763000747473
• UDI-Public: (01)00763000747473(17)271208(10)747015025B(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K253409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: C320LBBS45
• Device Catalogue Number: C320LBBS45
• Device Lot Number: 747015025B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2025
• 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 Sex: Female