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

Model Number	1601
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994)
Date of Event	05/31/2025
Type of Reportable Event	Serious Injury
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 pne trial and was in extreme pain following the procedure and unable to communicate.At the time of programming the epg, the patient was unable to feel anything.The patient was given a large dose of pain medication making it difficult to communicate.The next day the patient stated multiple times that she didn't feel anything but mentioned she was having muscle spasms.The stimulation was then turned down and that helped the patient to not be in discomfort at that time.A few days following, the patient was still in discomfort and the company representative had to turn off her stimulation completely.The patient stated she was going to the er because her entire body was sore.Reprogramming was attempted again with the on-call urologist at the er visit and the patient was still in pain.The device was turned off again and advised to see her implanting physician for a lead pull.
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 analysis of the product could be performed.The reported device performance allegation cannot be confirmed.A dhr review was performed and the review of the dhrs found no non-conformances.All established specifications and criteria for release were met.The patient symptom is a known risk associated with this device type/procedure and it is noted as such as in the instructions for use.
Event or Problem Description
It was reported that a patient had a pne trial and was in extreme pain following the procedure and unable to communicate.At the time of programming the epg, the patient was unable to feel anything.The patient was given a large dose of pain medication making it difficult to communicate.The next day the patient stated multiple times that she didn't feel anything but mentioned she was having muscle spasms.The stimulation was then turned down and that helped the patient to not be in discomfort at that time.A few days following, the patient was still in discomfort and the company representative had to turn off her stimulation completely.The patient stated she was going to the er because her entire body was sore.Reprogramming was attempted again with the on-call urologist at the er visit and the patient was still in pain.The device was turned off again and advised to see her implanting physician for a lead pull.

• 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 MODULATION TECHNOLOGIES, INC.; 26 technology dr; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22331314
• Report Number: 2124215-2025-39651
• Device Sequence Number: 13157288
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: (01)10810005340059
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 10/27/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1601
• Device Catalogue Number: 1601
• 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: 06/01/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 10/27/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown