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

Model Number	1101
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable neurostimulator (ins) contacted the clinic expressing frustration with the need for frequent charging and lack of therapeutic improvement.The patient reported that therapy had not provided sustained benefit despite multiple programming adjustments.At the time of evaluation, the patient was on program p1l2 and reported perceiving stimulation bilaterally.The patient reported that available programs did not provide symptom relief.Due to continued lack of perceived benefit, the patient underwent device explantation.No further patient complications were reported.
Additional Manufacturer Narrative
Block d2b: additional pro code: qon.Block g4: additional pma number: p190006.Block h11: investiagation results: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Good faith effort attempts were made to retrieve the device; however, the device was disposed of by the explanting provider.It was confirmed that the device met manufacturing specifications prior to distribution, and there were no manufacturing deviations that could have contributed to the reported event.Review of the instructions for use confirmed that there was relevant content and sufficient guidance related to the circumstances described in this complaint.No updates to the instructions for use are required as a result of this event.A risk review was completed and confirmed that the event type device explanation and inadequate treatment were defined in the product risk documentation.This event type has been accounted for during analysis to support an acceptable risk benefit profile of 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.Concomitant product: model number/catalog number: 1201, serial number: (b)(6), batch/lot number: al1u411884, model/catalog description: tined lead kit, unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient with this implantable neurostimulator (ins) contacted the clinic expressing frustration with the need for frequent charging and lack of therapeutic improvement.The patient reported that therapy had not provided sustained benefit despite multiple programming adjustments.At the time of evaluation, the patient was on program p1l2 and reported perceiving stimulation bilaterally.The patient reported that available programs did not provide symptom relief.Due to continued lack of perceived benefit, the patient underwent device explantation.No further patient complications were reported.
Additional Manufacturer Narrative
Block d2b: additional pro code: qon block g4: additional pma number: p190006 block h11: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.It was confirmed that the device met manufacturing specifications prior to distribution, and there were no manufacturing deviations that could have contributed to the reported event.Review of the instructions for use confirmed that there was relevant content and sufficient guidance related to the circumstances described in this complaint.No updates to the instructions for use are required as a result of this event.A risk review was completed and confirmed that the event type therapy delivery/effectiveness problem, inadequate treatment and device explantation were defined in the product risk documentation.This event type has been accounted for during analysis to support an acceptable risk benefit profile of the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Concomitant product: model number/catalog number: 1201 serial number: (b)(6) batch/lot number: al1u411884 model/catalog description: tined lead kit unique identifier (udi) #: (b)(4).

• 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: 25319794
• Report Number: 2124215-2026-28681
• Device Sequence Number: 5267583
• Product Code: EZW
• UDI-Device Identifier: 10810005340066
• UDI-Public: (01)10810005340066(11)210812(17)240812
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 08/12/2024
• Device Model Number: 1101
• Device Catalogue Number: 1101
• Device Lot Number: AX1H177335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/23/2026
• Date Device Manufactured: 08/12/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female