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

Model Number	1701
Medical Device Problem Codes	Fracture (1260); Unexpected Therapeutic Results (1631); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there were 6 cases of lead breakage/fracture, in all cases at the identical side of the lead, directly located at the transition from the rigid section to its flexible section.These all occurred during trial stages after the lead had been placed in the patient.In most cases, the fracture resulted in loss of isolation and exposure of the cable core/strand with short circuit, loss of connectivity to the patient's remote, loss of device function, and termination of the testing phase due to the removal of the lead.The physician is having to consider switching back to the previous trial device they've used for the time being because of the issue that occurred in the most recent 6 cases until the issue is resolved.
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 during the trial stage the percutaneous extension lead (pne) fractured at the transition from the rigid section to the flexible section.The fractured resulted in loss of isolation, exposure of the cable core or strand with short circuit, loss of connectivity to the patient's remote, loss of device function and termination of the testing phase due to removal of the lead.No further patient complications were reported.
Additional Manufacturer Narrative
Block d2b: product code - additional product code qon block g4: premarket / 510(k) # - additional premarket/510(k) p190006 block h11: corrections: block b1: adverse event or product problem block b2: outcomes attributed to adverse events block b5: describe event or problem block d3: manufacturer email block h6: device codes this event does not report any product malfunction, nor is there any allegation of patient/user harm.Upon further review by the manufacturer, this was determined to not meet the criteria for a reportable event.

• 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: 24958586
• Report Number: 2124215-2026-21876
• Device Sequence Number: 9890400
• Product Code: EZW
• UDI-Device Identifier: 10810005340134
• UDI-Public: (01)10810005340134(11)241120(17)270531(10)AK10000050
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/22/2026

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: 1701
• Device Catalogue Number: 1701
• Device Lot Number: AK10000050
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/22/2026
• Date Device Manufactured: 11/20/2024
• 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: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown