Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AXONICS, INC AXONICS; NEUROSTIMULATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AXONICS, INC AXONICS; NEUROSTIMULATOR Back to Search Results
Model Number 1801
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Incontinence (1928)
Date of Event 05/23/2024
Type of Reportable Event Malfunction
Event or Problem Description
The introducer sheath broke off inside the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AXONICS
Common Device Name
NEUROSTIMULATOR
Manufacturer (Section D)
AXONICS, INC
26 technology drive
irvine CA 92618
Manufacturer Contact
james nguyen
26 technology drive
irvine, CA 92618
MDR Report Key19585172
Report Number3002968685-2024-00126
Device Sequence Number17973467
Product Code EZW
UDI-Device Identifier10810005340080
UDI-Public10810005340080
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P180046
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2023
Device Explanted Year2023
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Company Representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/21/2024
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? Yes
Operator of Device Health Professional
Device Model Number1801
Device Lot NumberAS1H240009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2024
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/24/2024
Initial Report FDA Received Date06/21/2024
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured02/09/2024
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient Age38 YR
Patient SexFemale
-
-