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

Model Number	1701
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Undesired Nerve Stimulation (1980); Pain (1994); Perforation (2001); Discomfort (2330); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	11/04/2025
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 with this neurostimulator going through a trial stage was admitted to the hospital for a workup of internal bleeding.The procedure was performed under fluoroscopy.The patient was programmed post-operatively with feeling stimulation in the proper area on both programs, and no concerns or abnormalities were noted at that time.Follow-up calls were made daily after the procedure, and the patient reported improvements in their bowel and bladder symptoms, continuation of comfortable stimulation with no issues, concerns, or complaints.On (b)(6) 2025, the patient called requesting help to increase their stimulation as they were not feeling it, and the adjustment was made to increase the stimulation.There were no complaints or discomfort at the time.The patient called back later in the day, complaining of uncomfortable pressure in their rectum.Stimulation was decreased until they were comfortable but did have trouble connecting their remote to their external trial stimulator at the time of the call.The patient called back again and expressed concern about still having discomfort, so they decided to turn off the stimulation and then re-evaluate within a couple of hours to rule out stimulation for the determination of other factors contributing that would need to be evaluated.The patient called back an hour later, complaining of progressing discomfort, and since the stimulation has been off and discomfort continues, to keep the therapy off and be evaluated by a provider.The patient went to the er, and the er provider contacted the on-call provider from the implanting physician's office, who instructed that the complaint would not be device-related.With further workup, they diagnosed the patient with internal bleeding likely from a perforated artery from the percutaneous extension procedure.The patient was admitted to the hospital.Follow up reported that the patient was doing better.They were able to get the bleeding to stop.The patient had also been on xaretto and quit a couple of days before the trial procedure and started it back up a couple of days after the trial.It was further noted that the patient had the leads removed and was doing well.Currently, they need to get off of xarelto but are cautious as it could create a bleed if the patient happens to fall.It was further noted that the physician found two hemorrhoids in their rectal area, one inside and one on the outside.The outside one, they put lidocaine on and injected it and cut it off.The internal bleeding has stopped.The physician is assessing which area to address next, the internal hemorrhoid or to get the patient on the watchman device.There were no additional patient complications.

• 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: 23705396
• Report Number: 2124215-2025-85604
• Device Sequence Number: 10649500
• Product Code: EZW
• UDI-Device Identifier: 10810005340134
• UDI-Public: (01)10810005340134(11)250604(17)270531(10)AK10000240
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/29/2026

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: 1701
• Device Catalogue Number: 1701
• Device Lot Number: AK10000240
• 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: 11/08/2025
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 06/04/2025
• 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; Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female