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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a lead was frayed when removing it from the patient.The doctor cut the lead, disposed of the frayed portion, covered the remaining lead, and sent the patient home on antibiotics.The physician believes the lead started fraying upon removal.The physician was later advised to remove it in an operating room as soon as possible.The patient is scheduled for removal on (b)(6) 2025.The complaint was reported in error.The reporting physician is a colleague of the implanting physician and covered their duties while on vacation.The lead was incorrectly identified as frayed.The lead was pulled out in-clinic by the implanting physician.It came out as normal, fully intact and not frayed.The patient has tolerated everything well and will move forward with the permanent implant.The physician reported no product complaints or problems at this time.
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 lead was frayed when removing it from the patient.The doctor cut the lead, disposed of the frayed portion, covered the remaining lead, and sent the patient home on antibiotics.The physician believes the lead started fraying upon removal.The physician was later advised to remove it in an operating room as soon as possible.The patient is scheduled for removal on (b)(6) 2025.The complaint was reported in error.The reporting physician is a colleague of the implanting physician and covered their duties while on vacation.The lead was incorrectly identified as frayed.The lead was pulled out in-clinic by the implanting physician.It came out as normal, fully intact and not frayed.The patient has tolerated everything well and will move forward with the permanent implant.The physician reported no product complaints or problems at this time.
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.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: 22681302
• Report Number: 2124215-2025-53001
• Device Sequence Number: 8892205
• Product Code: EZW
• UDI-Device Identifier: 10810005340127
• UDI-Public: (01)10810005340127
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 02/24/2026

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
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 02/24/2026
• 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: 75 YR
• Patient Sex: Female