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	Discomfort (2330); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable neurostimulator (ins) experienced uncomfortable stimulation since implantation.Multiple programming adjustments were attempted without resolution.The patient reported discomfort and stimulation radiating down the leg, including during a period when stimulation was reportedly turned off.Additional information received indicated that the device was subsequently explanted.No further patient complications were reported.
Event or Problem Description
It was reported that the patient with this implantable neurostimulator (ins) experienced uncomfortable stimulation since implantation.Multiple programming adjustments were attempted without resolution.The patient reported discomfort and stimulation radiating down the leg, including during a period when stimulation was reportedly turned off.Additional information received indicated that the device was subsequently explanted.No further patient complications were reported.
Additional Manufacturer Narrative
Block d2b: additional pro code: qon.Block g4: pma number: p190006.Block h11: investigation results: block h11.Investigation details: the device was not returned for analysis; therefore, a technical analysis could not be performed.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 undesired sensations, non target stimulation area was 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.
Additional Manufacturer Narrative
Additional information: block d6b: explant date and concomitant product.Correction: block h11: investigation results.Block d2b: additional pro code: qon.

• 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: 50046737
• Report Number: 2124215-2026-40173
• Device Sequence Number: 10635810
• Product Code: EZW
• UDI-Device Identifier: 10810005340479
• UDI-Public: (01)10810005340479(11)241209(17)271209
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2026

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 Model Number: 5101
• Device Catalogue Number: 5101
• Device Lot Number: AX1G204481
• 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: 07/01/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 12/09/2024
• 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: 68 YR
• Patient Sex: Female