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

Model Number	1801
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional pro code qon.Block g4: additional premarket / 510 (k) p190006.
Event or Problem Description
It was reported that the physician had the sheath in the foramen, but was not receiving the desired results when the lead was introduced, so it was discussed to try a new needle placement.The physician said to take the sheath out, but wanted to keep it as a backup.The physician proceeded to put a new needle in the same foramen as the sheath.Once the desired results were achieved with that needle, the physician then pulled out the sheath.In doing so, they realized that the needle had punctured the existing sheath in the foramen and had trapped part of the sheath under the needle.They removed the needle to see if they could retrieve the sheath segment containing the radiopaque marker.The physician tried to retrieve the sheath but was unsuccessful.There were no patient complications.
Event or Problem Description
It was reported that the physician had the sheath in the foramen, but was not receiving the desired results when the lead was introduced, so it was discussed to try a new needle placement.The physician said to take the sheath out, but wanted to keep it as a backup.The physician proceeded to put a new needle in the same foramen as the sheath.Once the desired results were achieved with that needle, the physician then pulled out the sheath.In doing so, they realized that the needle had punctured the existing sheath in the foramen and had trapped part of the sheath under the needle.They removed the needle to see if they could retrieve the sheath segment containing the radiopaque marker.The physician tried to retrieve the sheath but was unsuccessful.There were no patient complications.
Additional Manufacturer Narrative
Block d2b: additional pro code qon.Block g4: additional premarket / 510 (k) p190006.The device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, device was discarded.It was confirmed the device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of device/component broken/separated during procedure, unretrieved device fragments (udf) was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 24641791
• Report Number: 2124215-2026-15294
• Device Sequence Number: 18621531
• Product Code: EZW
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: 1801
• Device Catalogue Number: 1801
• Device Lot Number: AS1G141003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 06/16/2026
• Date Device Manufactured: 01/02/2024
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: White