MAUDE Adverse Event Report: AXONICS, INC. AXONICS BLADDER DEVICE; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Device Problems No Device Output (1435); Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient stated that their bladder is "rejecting" the axonics device and it is not working.Patient stated they want to get the device removed and mdt device implanted.Patient stated the hcp they saw is not willing to remove their axonics device.Patient stated they have been dealing with this issue for "almost a year" medtronic reference number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AXONICS BLADDER DEVICE
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): AXONICS, INC.
• MDR Report Key: 17488061
• MDR Text Key: 320694514
• Report Number: MW5120785
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1