MAUDE Adverse Event Report: AXONICS, INC. IMPLANTED ELECTRICAL DEVICE INTENDED FOR TREATMENT OF FECAL INCONTINENCE

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

They have the axonics one and it hasn¿t worked well for them.Their customer after care sucks! they are about ready to have it removed.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTED ELECTRICAL DEVICE INTENDED FOR TREATMENT OF FECAL INCONTINENCE
• Type of Device: IMPLANTED ELECTRICAL DEVICE INTENDED FOR TREATMENT OF FECAL INCONTINENCE
• Manufacturer (Section D): AXONICS, INC.
• MDR Report Key: 17333190
• MDR Text Key: 319497410
• Report Number: MW5119451
• Device Sequence Number: 1
• Product Code: QON
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1