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

Model Number	1601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Device Overstimulation of Tissue (1991); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Musculoskeletal problem (4535); Urinary Incontinence (4572)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced extreme back pain and stiffness during and after the trial.They believe that there was a glitch between the clinician programmer and the remote control that caused her to receive overstimulation.The patient went to the emergency room where an mri was performed to confirm a hematoma.The device was removed but the patient is still experiencing back pain and stiffness.The patient was instructed to seek medical attention.It was reported two days later that patient is still experiencing severe right leg and buttock pain, back stiffness, mobility issues, and spasms causing uncontrolled urination despite the use of muscle relaxers.The patient believes the trial may have caused nerve damage.They expressed dissatisfaction with field support.Particularly that the stimulator was not turned off having a high stimulation setting during the hospital visit.The patient was advised to consult with their physician.The representative later reported that the patient left the stimulation on despite several occasions where they were advised to turn stimulation down or off.They also reported the patient went to the emergency room claiming the doctor, or staff dropped them in the operating room.
Additional Manufacturer Narrative
Product code (d2b): additional product code qon.Premarket/510(k) # (g4): additional premarket/510(k) # p190006.Updated b5.
Event or Problem Description
It was reported that the patient experienced extreme back pain and stiffness during and after the trial.They believe that there was a glitch between the clinician programmer and the remote control that caused her to receive overstimulation.The patient went to the emergency room where an mri was performed to confirm a hematoma.The device was removed but the patient is still experiencing back pain and stiffness.The patient was instructed to seek medical attention.It was later reported that the patient is still in pain.They were advised to contact the treating physician.The patient wants to understand the effects of overstimulation over a 48 hour period.The patient feels there was a glitch with the cp and the remote.They also noted the stimulation had been left at a high setting, with sensation experienced only in the back.Patient was advised repeatedly to contact their physician for any medical concerns.It was reported two days later that patient is still experiencing severe right leg and buttock pain, back stiffness, mobility issues, and spasms causing uncontrolled urination despite the use of muscle relaxers.The patient believes the trial may have caused nerve damage.They expressed dissatisfaction with field support.Particularly that the stimulator was not turned off having a high stimulation setting during the hospital visit.The patient was advised to consult with their physician.The representative later reported that the patient left the stimulation on despite several occasions where they were advised to turn stimulation down or off.They also reported the patient went to the emergency room claiming the doctor, or staff dropped them in the operating room.
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.Based on this investigation, the investigation conclusion code of 'known inherent risk of device' was chosen as the allegation relates to "hematoma", "incontinence, urinary", "muscle spasm", "musculoskeletal stiffness or spasm, not stimulation-related", "overstimulation of tissue" and "pain" 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.
Event or Problem Description
It was reported that the patient experienced extreme back pain and stiffness during and after the trial.They believe that there was a glitch between the clinician programmer and the remote control that caused her to receive overstimulation.The patient went to the emergency room where an mri was performed to confirm a hematoma.The device was removed but the patient is still experiencing back pain and stiffness.The patient was instructed to seek medical attention.It was later reported that the patient is still in pain.They were advised to contact the treating physician.The patient wants to understand the effects of overstimulation over a 48-hour period.The patient feels there was a glitch with the cp and the remote.They also noted the stimulation had been left at a high setting, with sensation experienced only in the back.Patient was advised repeatedly to contact their physician for any medical concerns.It was reported two days later that patient is still experiencing severe right leg and buttock pain, back stiffness, mobility issues, and spasms causing uncontrolled urination despite the use of muscle relaxers.The patient believes the trial may have caused nerve damage.They expressed dissatisfaction with field support.Particularly that the stimulator was not turned off having a high stimulation setting during the hospital visit.The patient was advised to consult with their physician.The representative later reported that the patient left the stimulation on despite several occasions where they were advised to turn stimulation down or off.They also reported the patient went to the emergency room claiming the doctor, or staff dropped them in the operating room.

• 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: 22376514
• Report Number: 2124215-2025-43276
• Device Sequence Number: 4437276
• 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
• Device Implanted 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,Followup
• Report Date (Section B): 11/24/2025

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: 1601
• Device Catalogue Number: 1601
• Device Lot Number: AE1S843798
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 10/30/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/31/2025; 11/24/2025
• Date Device Manufactured: 08/24/2024
• 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: Other
• Patient Age: 40 YR
• Patient Sex: Female