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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Patient reported they'd had 3 surgeries for an axonics device because the same thing had happened with axonics.The patient stated the axonic ins' were also both infected and the one battery had been coming out of their skin (a "total failure") so the managing health care provider (hcp) had removed all of it at that time.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): AXONICS, INC.
• MDR Report Key: 17488332
• MDR Text Key: 320690208
• Report Number: MW5121030
• 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: 12/01/2022

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