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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 Material Erosion (1214)
Health Effect - Clinical Code Erosion (1750)
Date of Event 04/09/2020
Type of Reportable Event Malfunction
Event or Problem Description
Patient underwent a rapid weight loss program where they had lost 38 pounds in 2 months.The doctor stated the lead stress coil at the ipg (neurostimulator) site had eroded through the skin.The patient was scheduled for a full system explant 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 Key10039444
Report Number3002968685-2020-00038
Device Sequence Number2812737
Product Code EZW
UDI-Device Identifier10810005340158
UDI-Public10810005340158
Combination Product (Y/N)N
Initial Reporter StateCA
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) 06/05/2020
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 Lay User/Patient
Device Model Number2201
Device Catalogue Number2201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2020
Initial Date Received by Manufacturer 04/09/2020
Supplement Date Received by Manufacturer04/09/2020
Initial Report FDA Received Date05/08/2020
Supplement Report FDA Received Date06/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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