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

Model Number	5101
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Rash (2033); Urinary Retention (2119); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this neurostimulator (ins) was experiencing shocking sensations, has been sensitive to stimulation, and has noticeable blistering/abrasions at the ins site.The patient noted that since about august, the ins has started surfacing.The patient had many instances of the blistering opening up and healing, but no infection was reported, and it has been very painful.The patient has made several er trips for pain and retention.At these visits, they have been prescribed fentanyl and has taken kratom for the pain as well.A revision of the lead and ins is planned but not yet scheduled.The patient underwent a lead replacement and revised neurostimulator on (b)(6) 2026.No further patient complications were reported.
Additional Manufacturer Narrative
Block d2b: additional pro code qon.Block d10: model number/catalog number: 1201 serial number: (b)(6).Batch/lot number: al1r641019 model/catalog description: tined lead unique identifier (udi) #: (b)(4).Block g4: 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: 25164860
• Report Number: 2124215-2026-25965
• Device Sequence Number: 16110150
• Product Code: EZW
• UDI-Device Identifier: 10810005340479
• UDI-Public: (01)10810005340479(11)240617(17)270617
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 06/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5101
• Device Catalogue Number: 5101
• Device Lot Number: AX1G200693
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 20 YR
• Patient Sex: Unknown