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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 1101
Device Problem Wireless Communication Problem (3283)
Patient Problem Failure of Implant (1924)
Event Date 06/15/2020
Event Type  malfunction  
Event Description
Patient has been unable to successfully charge the ipg (neurostimulator) with the charging device.On (b)(6) 2020, patient was able to connect to the ipg, but only for 5 minutes before connection was lost.Multiple attempts were made to reposition the charging device in different locations, but still unable to connect to the ipg.On (b)(6) 2020, a pocket revision was performed, but the ipg and charging device would still not connect.The ipg was then explanted on (b)(6) 2020.
 
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Brand Name
AXONICS
Type of Device
NEUROSTIMULATOR
Manufacturer (Section D)
AXONICS MODULATION TECHNOLOGIES, INC.
26 technology drive
irvine CA
Manufacturer Contact
peter vu
26 technology drive
irvine, CA 
9493364590
MDR Report Key10280563
MDR Text Key202790074
Report Number3002968685-2020-00056
Device Sequence Number1
Product Code EZW
UDI-Device Identifier10810005340066
UDI-Public10810005340066
Combination Product (y/n)N
PMA/PMN Number
P180046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/2020
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
Device Operator Lay User/Patient
Device Expiration Date02/19/2022
Device Model Number1101
Device Catalogue Number1101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2020
Initial Date Manufacturer Received 06/17/2020
Initial Date FDA Received07/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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