MAUDE Adverse Event Report: Axonics Modulation Technologies, Inc. Axonics; Stimulator, Electrical, Implantable, For Incontinence

Model Number	5101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with the neurostimulator (ins) experienced painful "zapping" sensations when turning stimulation off on three separate occasions, including before two mri procedures and a low back ablation.During the most recent mri on (b)(6) 2026, the sensation was reported as significantly more painful.After stimulation was turned back on following the mri, they continued to experience intermittent zapping while walking and bending over.They turned stimulation off again on (b)(6) 2026, after which the zapping resolved.The sensation was localized approximately three to four inches above and slightly to the right of the implanted neurostimulator in the right buttock.They were unsure whether the sensation was related to the device or a back nerve issue and reported no red light on the remote.Troubleshooting consisted of turning stimulation off, which resolved the issue.The patient was met in the office to troubleshoot.The physician considered the device's contribution to the undesired stimulation and pain to be unknown.When connected with the clinician programmer (cp), there was no error message.However, it did cause significant pain, as they felt a strong zap again.There were no impedance issues seen.While checking impedances, there was more painful zapping with sensations going from the lower back down to the vaginal area.Stimulation remained off the entire time.The patient underwent an ins and tined lead revision on (b)(6) 2026.
Additional Manufacturer Narrative
Block d2b:.Additional pro code: qon.Block d10: model number/catalog number: 1201.Serial number: (b)(6).Batch/lot number: al1sa42166.Model/catalog description: 1201.Unique identifier (udi) #: (b)(4).Block g4: additional premarket / 510 (k): p190006.Detailed product investigation has not been provided.We complete a good faith effort to obtain information.Because the product investigation is unknown at this time, we are unable to provide the product investigation and other specific product information.If additional details become available, a supplemental report will be submitted.

• 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: 50609793
• Report Number: 2124215-2026-47253
• Device Sequence Number: 21491282
• Product Code: EZW
• UDI-Device Identifier: 10810005340479
• UDI-Public: (01)10810005340479(11)240322(17)270322
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 5101
• Device Catalogue Number: 5101
• Device Lot Number: AX1G198064
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 03/22/2024
• 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: 59 YR
• Patient Sex: Female