MAUDE Adverse Event Report: Axonics Modulation Technologies, Inc. Axonics; Stimulator, Electrical, Implantable, For Incontinence

Model Number	5101
Medical Device Problem Codes	High impedance (1291); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with a rechargeable snm ipg had a red-light error on their remote that would not clear.All high (open) impedances were discovered, and the error could not be cleared in clinic.A successful revision was done on the patient, with both lead and battery replaced.The patient was doing well post procedure.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block d2b: product code - additional product code qon.Block d10: model number/catalog number: 1201.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: snm tined lead.Unique identifier (udi) #(b)(4).Block g4: premarket / 510(k) # - additional premarket/510(k) p190006.H11: investigation details the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, device was discarded.It was confirmed the device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of caused not established.

• Brand Name: Axonics
• Common Device Name: Stimulator, Electrical, Implantable, For Incontinence
• Manufacturer (Section D): Axonics Modulation Technologies, Inc.; 15515 sand canyon ave; irvine CA 92618
• Manufacturer (Section G): Axonics Inc; 26 technology dr; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50614759
• Report Number: 2124215-2026-47122
• Device Sequence Number: 16137961
• Product Code: EZW
• UDI-Device Identifier: 10810005340479
• UDI-Public: (01)10810005340479(11)230626(17)260626
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/26/2026
• Device Model Number: 5101
• Device Catalogue Number: 5101
• Device Lot Number: AX1G192378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 06/26/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female