MAUDE Adverse Event Report: Axonics Modulation Technologies, Inc Axonics; Stimulator, Electrical, Implantable, For Incontinence

Model Number	4101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this neurostimulator (ins) went to the emergency department due to pain.Upon examination, it was noted that the patient's ins had eroded through the skin.Then the patient had surgery to explant their ins and tined lead.There was no infection noted at the time, but they are waiting for the report on the intra-op swab.The patient was closed up and sent home.Additionally, per the physician, there was no infection present from the swab.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon udi for concomitant product, tined lead: block d10: model number/catalog number: 1201.Serial number: (b)(6) batch/lot number: al10022498.Model/catalog description: tined lead.Unique identifier (udi) #: (b)(4).Block g4: premarket / 510(k) #: additional premarket / 510(k) # p190006.

• 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; 15515 sand canyon ave; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50515465
• Report Number: 2124215-2026-46177
• Device Sequence Number: 10716397
• Product Code: EZW
• UDI-Device Identifier: 10810005340455
• UDI-Public: (01)10810005340455(11)250724(17)280724
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: 4101
• Device Catalogue Number: 4101
• Device Lot Number: AX1T104255
• 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: 08/05/2026
• Initial Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 07/24/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female