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

Model Number	1901
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the initial pne lead placement, adequate responses were not being produced, so the original lead was removed, and another lead was placed.During the removal of the first lead, it was noticed that the tip had broken off and was presumably still in the patient.An x-ray would be ordered to assess once the pne test is completed and the wires are removed 2 weeks later.There were no additional patient complications reported, and no further information has been obtained to date.
Additional Manufacturer Narrative
Product code (d2b) - additional product code qon premarket / 510(k) # (g4) - additional premarket / 510(k) # p190006.
Event or Problem Description
It was reported that during the initial pne lead placement, adequate responses were not being produced, so the original lead was removed, and another lead was placed.During the removal of the first lead, it was noticed that the tip had broken off and was presumably still in the patient.An x-ray would be ordered to assess once the pne test is completed and the wires are removed 2 weeks later.There were no additional patient complications reported, and no further information has been obtained to date.
Additional Manufacturer Narrative
Product code (d2b), additional product code qon.Premarket / 510(k) # (g4), additional premarket / 510(k) # p190006.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available the cause that contributed to the reported event cannot be established.
Additional Manufacturer Narrative
Block h11: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Good faith effort attempts were made to try and retrieve the device, however the device was retained by the explanting provider.A dhr review could not be performed because the complaint lacked adequate information to perform a search.Reoperation or revision, device fracture or failure, and suspected technical device malfunction is an inherent adverse event that is possible with implantation and use as listed in the information for prescribers and patients insert.The presence of unretrieved device fragments is addressed within the applicable risk documentation per the medical review.A risk review was completed and confirmed that the event of fracture and unretrieved device fragments was defined in the product risk documentation per medical review.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 unable to exclude device problem.
Event or Problem Description
It was reported that during the initial pne lead placement, adequate responses were not being produced, so the original lead was removed, and another lead was placed.During the removal of the first lead, it was noticed that the tip had broken off and was presumably still in the patient.An x-ray would be ordered to assess once the pne test is completed and the wires are removed 2 weeks later.There were no additional patient complications reported, and no further information has been obtained to date.
Additional Manufacturer Narrative
Block d2b: product code: additional product code qon.Block g4: premarket / 510(k) #: additional premarket/510(k) p190006.Block h11: the device was not returned for analysis; therefore, a technical analysis could not be performed.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 fracture and unretrieved device fragments was defined in the product risk documentation per medical review.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 unable to exclude device problem.
Event or Problem Description
It was reported that during the initial pne lead placement, adequate responses were not being produced, so the original lead was removed, and another lead was placed.During the removal of the first lead, it was noticed that the tip had broken off and was presumably still in the patient.An x-ray would be ordered to assess once the pne test is completed and the wires are removed 2 weeks later.There were no additional patient complications reported, and no further information has been obtained to date.

• 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: 23783877
• Report Number: 2124215-2025-90269
• Device Sequence Number: 10389556
• Product Code: EZW
• UDI-Device Identifier: 10810005340127
• UDI-Public: (01)10810005340127
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/08/2026

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: Lay User/Patient
• Device Model Number: 1901
• Device Catalogue Number: 1901
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/12/2026; 03/12/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/09/2026; 03/11/2026; 04/08/2026
• 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; Required Intervention
• Patient Sex: Unknown