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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AXONICS MODULATION TECHNOLOGIES, INC. AXONICS; NEUROSTIMULATOR
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AXONICS MODULATION TECHNOLOGIES, INC. AXONICS; NEUROSTIMULATOR Back to Search Results
Model Number 2201
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 01/31/2020
Type of Reportable Event Malfunction
Event or Problem Description
The patient stated they were not feeling much stimulation and what was felt was different than the sensations the patient felt during the trial period.They were also feeling pain.X-ray images were taken and it was observed that the lead had migrated.The lead was replaced on (b)(6) 2020.
 
Event or Problem Description
See section h, number 6, event problem and evaluation codes.
 
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Brand Name
AXONICS
Common Device Name
NEUROSTIMULATOR
Manufacturer (Section D)
AXONICS MODULATION TECHNOLOGIES, INC.
26 technology drive
irvine CA
MDR Report Key9772183
Report Number3002968685-2020-00015
Device Sequence Number1866137
Product Code EZW
UDI-Device Identifier10810005340158
UDI-Public10810005340158
Combination Product (Y/N)N
Initial Reporter StateWA
PMA/510(K) Number
P180046
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/27/2020
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 Expiration Date01/03/2021
Device Model Number2201
Device Catalogue Number2201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2020
Initial Date Received by Manufacturer 02/03/2020
Supplement Date Received by Manufacturer02/03/2020
Initial Report FDA Received Date02/28/2020
Supplement Report FDA Received Date03/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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