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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 11/11/2021

Event Type  Injury  

Event Description

I had an axonics neurostimulation trial device installed.I have been in terrible pain ever since.The sales reps and nurse practitioner did not accurately document my complaints and tried to make me believe i was the problem.I had the device removed and declined to have the permanent one installed.I am still in pain.Fda safety report id # (b)(4).

• Brand Name: AXONICS NEURO STIMULATION TRIAL DEVICE
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): AXONICS INC.
• MDR Report Key: 12967447
• MDR Text Key: 282041112
• Report Number: MW5105931
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/06/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2021
• Patient Sequence Number: 1
• Treatment: ACYCLOVIR; FIRAZYR; TAKHZYRO
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White