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

Device Problems Energy Output Problem (1431); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)

Patient Problem Fall (1848)

Event Date 02/28/2022

Event Type  Injury  

Event Description

The reason for call was patient said that they fell on (b)(6) 2022 and since then they have been having issues with their therapy.The patient was told by their healthcare provider that they needed a new programmer because the healthcare provider had a hard time connecting their external equipment to patient's ins at patient's appt last friday but was able to successfully connect and increase stimulation.Patient said even though the hcp increased their stim last week, they are still having therapy issues so they are going to increase stim today and monitor symptoms.Later the rep noted that the patient was implanted with axonics in january and it is not our remote.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: 17353312
• MDR Text Key: 319426623
• Report Number: MW5119608
• 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: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1