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 Codes	Burn(s) (1757); Hematoma (1884); Pain (1994); Discomfort (2330); Skin Inflammation/ Irritation (4545)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient going through a trial stage experienced discomfort and tenderness at the site location where the lead exits the skin.The lead was pulled out on (b)(6) 2025, and the patient was prescribed augmentin, which ended on (b)(6) 2025.The patient stated that the discomfort in their buttocks is slowly improving, but it is still tender when sitting.The discomfort was described by the patient as more like a burn, but there's a hard core under it like a hematoma, which is slowly decreasing in size.The opening was about the size of a nickel.The patient thinks that it started as a burn and then progressed to a wound.The patient will continue to take antibiotics.The representative advised that the patient is doing much better.The patient was not prescribed any other antibiotics or medications.The discomfort and pain have gone away and the patient hasn't noticed it for the past few days.The physician is not sure what caused the patient's issue, and if it was an infection, they never got a clear diagnosis on it.The patient has a follow-up appointment with the physician on (b)(6) 2025, to discuss the next steps.There were no additional patient complications.
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 going through a trial stage experienced discomfort and tenderness at the site location where the lead exits the skin.The lead was pulled out on (b)(6) 2025, and the patient was prescribed augmentin, which ended on (b)(6) 2025.The patient stated that the discomfort in their buttocks is slowly improving, but it is still tender when sitting.The discomfort was described by the patient as more like a burn, but there's a hard core under it like a hematoma, which is slowly decreasing in size.The opening was about the size of a nickel.The patient thinks that it started as a burn and then progressed to a wound.The patient will continue to take antibiotics.The representative advised that the patient is doing much better.The patient was not prescribed any other antibiotics or medications.The discomfort and pain have gone away and the patient hasn't noticed it for the past few days.The physician is not sure what caused the patient's issue, and if it was an infection, they never got a clear diagnosis on it.The patient has a follow-up appointment with the physician on (b)(6) 2025, to discuss the next steps.There were no additional patient complications.
Additional Manufacturer Narrative
Product code (d2b) - additional product code qon premarket / 510(k) # (g4) - additional premarket/510(k) p190006 the supplemental record is being submitted for the product investigation conclusion and coding: 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.Based on this investigation, the investigation conclusion code of 'known inherent risk of device' was chosen as the allegations relate to "discomfort", "pain", "irritation, skin", "inflammation, skin", "burn(s)" and "hematoma" which are addressed in the product labeling and risk 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: 23236957
• Report Number: 2124215-2025-70227
• Device Sequence Number: 18329090
• Product Code: EZW
• UDI-Device Identifier: 10810005340127
• UDI-Public: (01)10810005340127
• 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: 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): 12/04/2025

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
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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: Other
• Patient Age: 86 YR
• Patient Sex: Male