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

Model Number	1601
Medical Device Problem Codes	Defective Device (2588); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the patient had a 3rd spacing of fluid, the patient's fluid was overloaded and needed a paracentesis.The patient had a paracentesis and then went into the clinic to have their external trial stimulator (ets) replaced.The patient had fluid draining from their perc extension site and the incision site, which caused the ets to no longer work.The remote was unable to be connected as well so the remote was attempted to be reset.The clinic bandaged the dressing so that the ets was not visible, and therefore, it was unknown if a red light was seen.The patient was scheduled for troubleshooting the day after their paracentesis.Then, the ets was replaced and wrapped with tegaderm to prevent any further events of the ets getting wet.No patient complications were reported.
Additional Manufacturer Narrative
Product code (d2b) - additional product code qon premarket / 510(k) # (g4)- additional premarket/510(k) p190006.
Additional Manufacturer Narrative
The following fields were corrected h6 device codes.Product code (d2b) - additional product code qon.Premarket / 510(k) # (g4)- additional premarket/510(k) p190006.
Event or Problem Description
It was reported that after the patient had a 3rd spacing of fluid, the patient's fluid was overloaded and needed a paracentesis.The patient had a paracentesis and then went into the clinic to have their external trial stimulator (ets) replaced.The patient had fluid draining from their perc extension site and the incision site, which caused the ets to no longer work.The remote was unable to be connected as well so the remote was attempted to be reset.The clinic bandaged the dressing so that the ets was not visible, and therefore, it was unknown if a red light was seen.The patient was scheduled for troubleshooting the day after their paracentesis.Then, the ets was replaced and wrapped with tegaderm to prevent any further events of the ets getting wet.No patient complications were reported.
Additional Manufacturer Narrative
The following fields were corrected h6 device codes.Product code (d2b) - additional product code qon.Premarket / 510(k) # (g4)- additional premarket/510(k) p190006.
Event or Problem Description
It was reported that after the patient had a 3rd spacing of fluid, the patient's fluid was overloaded and needed a paracentesis.The patient had a paracentesis and then went into the clinic to have their external trial stimulator (ets) replaced.The patient had fluid draining from their perc extension site and the incision site, which caused the ets to no longer work.The remote was unable to be connected as well so the remote was attempted to be reset.The clinic bandaged the dressing so that the ets was not visible, and therefore, it was unknown if a red light was seen.The patient was scheduled for troubleshooting the day after their paracentesis.Then, the ets was replaced and wrapped with tegaderm to prevent any further events of the ets getting wet.No patient complications were reported.

• 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: 22205711
• Report Number: 2124215-2025-38246
• Device Sequence Number: 17829174
• Product Code: EZW
• UDI-Device Identifier: 10810005340059
• UDI-Public: (01)10810005340059
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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: AE1S640332
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 08/08/2025; 08/27/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/09/2025; 09/19/2025
• Date Device Manufactured: 06/01/2024
• 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: 67 YR
• Patient Sex: Female