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	07/17/2026
Type of Reportable Event	Malfunction

• 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--439 ; +1(763)526-9277
• MDR Report Key: 50222500
• Report Number: 2182207-2026-02225
• Device Sequence Number: 18726168
• Product Code: DQY
• UDI-Device Identifier: 00763000747473
• UDI-Public: (01)00763000747473(17)280225(10)747010926C(20)01
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 747010926C
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 09/22/2026; 09/25/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/24/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2026
• 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: Unknown