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

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

The patient stated that their axonics device is not helping them and that they go "30-50" times a day and stop drinking after 1:30.Caller had said that patient symptom relief is at "less than 0" and they are in a lot of pain.They said they have tried contacting axonics and hcp (david williams).The patient said they want to have axonics device removed 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 INCONTINENCE
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): AXONICS, INC.
• MDR Report Key: 17488054
• MDR Text Key: 320682853
• Report Number: MW5120778
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1