MAUDE Adverse Event Report: AXONICS MODULATION TECHNOLOGIES, INC. AXONICS; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	5101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Numbness (2415); Implant Pain (4561)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: product code - additional product code qon.Block g4: premarket / 510(k) # - additional premarket/510(k) p190006.
Event or Problem Description
It was reported that the patient's daughter reached out to report that the patient is in excruciating pain in the lower back which radiated down the right leg through the foot as well as left leg.The patient also complained of vaginal numbness.The patient was admitted to the emergency room.The patient has a history of mva and spinal surgeries.The implant is off while the physician orders tests to diagnose the issue.The physician believes that patient has pinched nerves which are causing the pain and did not think that the device was related to the patient's condition.There were no other issues or complications reported at this time.
Event or Problem Description
It was reported that the patient's daughter reached out to report that the patient is in excruciating pain in the lower back which radiated down the right leg through the foot as well as left leg.The patient also complained of vaginal numbness.The patient was admitted to the emergency room.The patient has a history of mva and spinal surgeries.The implant is off while the physician orders tests to diagnose the issue.The physician believes that patient has pinched nerves which are causing the pain and did not think that the device was related to the patients condition.There were no other issues or complications reported at this time.
Additional Manufacturer Narrative
Block d2b: product code - additional product code qon block g4: premarket / 510(k) # - additional premarket/510(k) p190006 block h11: 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 remains implanted.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.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the events of discomfort, pain, implant pain and the numbness can be related to illness (general) were defined in the product risk documentation.These event types have been accounted for during analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• 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: 25224912
• Report Number: 2124215-2026-27040
• Device Sequence Number: 15970911
• Product Code: EZW
• UDI-Device Identifier: 10810005340479
• UDI-Public: (01)10810005340479(11)230307(17)260307
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: 03/07/2026
• Device Model Number: 5101
• Device Catalogue Number: 5101
• Device Lot Number: AX1G191622
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/23/2026
• Date Device Manufactured: 03/07/2023
• 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: Other; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female