MAUDE Adverse Event Report: AXONICS MODULATION TECHNOLOGIES, INC. Axonics; Stimulator, Electrical, Implantable, For Incontinence

Model Number	5101
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	Inappropriate Device Stimulation of Tissue (4928)
Date of Event	04/20/2026
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.Udi for concomitant product, tined lead: block d10: model number/catalog number: 1201.Serial number: (b)(6).Batch/lot number: al1k333671.Model/catalog description: tined lead.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported the patient implanted with this neurostimulator experienced shocking sensation below their implant site and buttock area.They reported they felt the shocking sensation when sitting down.The patient denied any falls, procedures, nor received imaging.The patient was assisted with charging their device and no red lights on the remote control were present.Then it was discovered the patient has high impedance.The stimulation was turned off and the physician submitted orders for a revision surgery.Additionally, it was ultimately decided that the patient had surgery to explant their neurostimulator and tined lead with no replacement.Also, it was discovered during explant that the lead was fragmented.The local care team contacted the patient to determine their status, but the patient did not respond.
Event or Problem Description
It was reported the patient implanted with this neurostimulator experienced shocking sensation below their implant site and buttock area.They reported they felt the shocking sensation when sitting down.The patient denied any falls, procedures, nor received imaging.The patient was assisted with charging their device and no red lights on the remote control were present.Then it was discovered the patient had high impedance.The stimulation was turned off and the physician submitted orders for a revision surgery.Then, the patient had surgery to explant their neurostimulator and tined lead with no replacement.Also, it was discovered during explant that the lead was fragmented.The local care team contacted the patient to determine their status, but the patient did not respond.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon.Block g4: premarket / 510(k) #: additional premarket / 510(k) # p190006.Udi for concomitant product, tined lead: block d10: model number/catalog number: 1201 serial number:(b)(6) batch/lot number: al1k333671 model/catalog description: tined lead unique identifier (udi) #: (b)(4).Block 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, the product was disposed.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 high impedance, undesired sensations (non-target stimulation area), and fracture was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The media inspection was performed; however, the x-ray image could not confirm any failure or issues related to impedance or stimulation.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Correction: b5.

• 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; 15515 sand canyon ave; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25833716
• Report Number: 2124215-2026-38121
• Device Sequence Number: 10417543
• Product Code: EZW
• UDI-Device Identifier: 10810005340479
• UDI-Public: (01)10810005340479(11)230525(17)260525
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: 05/25/2026
• Device Model Number: 5101
• Device Catalogue Number: 5101
• Device Lot Number: AX1G191129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 05/25/2023
• 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: 80 YR
• Patient Sex: Male