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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AXONICS, INC. AXONICS; NEUROSTIMULATOR
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AXONICS, INC. AXONICS; NEUROSTIMULATOR Back to Search Results
Model Number 9009
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Drug Resistant Bacterial Infection (4553)
Date of Event 07/07/2022
Type of Reportable Event Serious Injury
Event or Problem Description
The company was made aware that a patient underwent an explant surgery due to mrsa infection.
 
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Brand Name
AXONICS
Common Device Name
NEUROSTIMULATOR
Manufacturer (Section D)
AXONICS, INC.
26 technology drive
irvine CA
Manufacturer Contact
azucena eulloqui
26 technology drive
irvine, CA 
9493364590
MDR Report Key15156993
Report Number3002968685-2022-00084
Device Sequence Number5321011
Product Code EZW
UDI-Device Identifier10810005340288
UDI-Public10810005340288
Combination Product (Y/N)N
Initial Reporter StateKS
PMA/510(K) Number
P180046
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2022
Device Explanted Year2022
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Health Professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/03/2022
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? No
Operator of Device Other
Device Expiration Date06/08/2024
Device Model Number9009
Device Catalogue Number9009
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/07/2022
Initial Report FDA Received Date08/03/2022
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured03/08/2022
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 SexUnknown
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