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

Model Number	1701
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a bilateral pne procedure, and during recovery the patient was unable to feel stimulation on both leads.The physician ordered an x-ray, which showed the leads had come out of the foramen and were sitting in their subcutaneous tissue.It was assumed by the physician that the leads had migrated when the patient was being transferred.The patient is not scheduled for a stage 1 procedure, and the physician has elected to go with medtronic product for the patient.There were no other issues or complications reported.
Additional Manufacturer Narrative
Product code (d2b) - additional product code qon.Premarket / 510(k) # (g4) - additional premarket/510(k) p190006.
Event or Problem Description
It was reported that a patient had a bilateral pne procedure, and during recovery the patient was unable to feel stimulation on both leads.The physician ordered an x-ray, which showed the leads had come out of the foramen and were sitting in their subcutaneous tissue.It was assumed by the physician that the leads had migrated when the patient was being transferred.The patient is scheduled for a stage 1 procedure, and the physician has elected to go with medtronic product for the patient.There were no other issues or complications reported.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon.Block g4: premarket / 510(k) #: additional premarket/510(k) p190006.Block h11: investigation details: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.Based on this investigation, the investigation conclusion code of 'known inherent risk of device' was chosen as the allegation relates to "device - migration, inadequate stimulation" which is addressed in the product labeling documentation.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.

• 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: 23923592
• Report Number: 2124215-2025-93695
• Device Sequence Number: 9082225
• Product Code: EZW
• UDI-Device Identifier: 10810005340134
• UDI-Public: (01)10810005340134(11)241115(17)270531(10)AK10000053
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 02/18/2026

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: 1701
• Device Catalogue Number: 1701
• Device Lot Number: AK10000053
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/18/2026
• Date Device Manufactured: 11/15/2024
• 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; Other; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female