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

Model Number	5101
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	04/13/2026
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 a patient felt like their implant battery had moved.The patient contacted their physician and stated that they also felt a tugging sensation under their skin.The physician thought it could be from the battery being displaced and pulling on the lead.X-rays were done and confirmed that the patient's implant battery had shifted in the pocket.A pocket revision was done on the patient which was successful.Following the procedure, the patient reached out to their representative and advised they are still experiencing the tugging sensation and tenderness when they touch their sacrum.The patient has contacted their physician also concerning this issue for next steps.No further patient complications were reported.No further information has been received to date.
Event or Problem Description
It was reported that the patient with this neurostimulator felt like their implant battery had moved.The patient felt a tugging sensation under their skin.The physician thought it could be from the battery being displaced and pulling on the lead.X-rays were done and confirmed that the patient's implant battery had shifted in the pocket.A pocket revision was done on the patient which was successful.Following the procedure, the patient reached out to their representative and advised they are still experiencing the tugging sensation and tenderness when they touch their sacrum.The patient has contacted their physician also concerning this issue for next steps.No further patient complications were reported.No further information has been received to date.
Additional Manufacturer Narrative
Block d2b: product code - additional product code qon block g4: premarket / 510(k) # - additional premarket/510(k) p190006 block h11: as the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.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 event of discomfort, pain, undesired sensations (non-target stimulation area), and device migration was defined in the product risk documentation.This event type has 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 cause not established.Corrections: block b1: adverse event / product problem block b2: outcomes block b5: describe event or problem block d3: manufacturer email.

• 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: 25085398
• Report Number: 2124215-2026-24306
• Device Sequence Number: 10533016
• Product Code: EZW
• UDI-Device Identifier: 10810005340479
• UDI-Public: (01)10810005340479(11)240923(17)270923
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/18/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 5101
• Device Catalogue Number: 5101
• Device Lot Number: AX1G196755
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 09/23/2024
• 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; Other; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female