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

Model Number	1101
Medical Device Problem Codes	Charging Problem (2892); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this neurostimulator began to experience charging issues, as the patient's baseline symptoms were returning.It was noted the remote would not connect as the device was going into hibernation mode.The charger was put over the ins to remove from hibernation mode.The charger connected to the ins and the patient was able to charge.It was confirmed the impedances were good; however, the battery was low.The patient charged the ins that night and the following morning for one hour and it was confirmed the battery was solid green.The remote failed to connect after four attempts and after resetting the remote, the connection was still unsuccessful.A different charger was used for 30 minutes before receiving the disconnect tone and when attempting to connect the patient's remote it flashed with an orange light before turning off.The patient met with the physician to troubleshoot and discuss ins revision.It was noted that impedances remain good and the battery was completely depleted.The ins went back into hibernation mode.The patient's ins was revised.No other patient complications were reported.
Additional Manufacturer Narrative
Block d2b: additional pro code qon.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; 26 technology dr; irvine CA 92618
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24831802
• Report Number: 2124215-2026-19330
• Device Sequence Number: 9169020
• Product Code: EZW
• UDI-Device Identifier: 10810005340066
• UDI-Public: (01)10810005340066(11)200630(17)220930
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 04/09/2026

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 Expiration Date: 09/30/2022
• Device Model Number: 1101
• Device Catalogue Number: 1101
• Device Lot Number: AX1H159116
• 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: 03/16/2026
• Initial Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 06/30/2020
• 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: 53 YR
• Patient Sex: Female
• Patient Race: White