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

Model Number	1901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was having lower back pain from the procedure and chose to have the leads removed early to end the basic trial.The patient was unable to sit or lay down due to soreness and pain in the back side.The physician attributed this pain to the procedure.There were no other reported complications.Medical/surgical intervention was required.The clinical specialist sent in an update stating the patient was still having some soreness after the leads were pulled, but no other complications were listed.
Additional Manufacturer Narrative
Product code (d2b) - additional product code qon premarket / 510(k) # (g4)- additional premarket/510(k) p190006.
Additional Manufacturer Narrative
Product code (d2b) - additional product code qon.Premarket / 510(k) # (g4)- additional premarket/510(k) p190006.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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient was having lower back pain from the procedure and chose to have the leads removed early to end the basic trial.The patient was unable to sit or lay down due to soreness and pain in the back side.The physician attributed this pain to the procedure.There were no other reported complications.Medical/surgical intervention was required.The clinical specialist sent in an update stating the patient was still having some soreness after the leads were pulled, but no other complications were listed.

• 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: 22441091
• Report Number: 2124215-2025-45284
• Device Sequence Number: 4670260
• Product Code: EZW
• UDI-Device Identifier: 10810005340127
• UDI-Public: (01)10810005340127
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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 Model Number: 1901
• Device Catalogue Number: 1901
• Device Lot Number: AK20000017
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 02/09/2026
• Date Device Manufactured: 06/07/2024
• 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
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Race: White