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; 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; NEUROSTIMULATOR Back to Search Results
Model Number 1701
Medical Device Problem Code Impedance Problem (2950)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/08/2020
Type of Reportable Event Malfunction
Event or Problem Description
Pne lead impedances were all green until patient was dressed.Once patient was dressed, lead number 2 and ground pad showed red impedances.Dressing was removed and impedances became intermittently green and red.The ground pad was removed and the impedances on both lead number 1 and 2 were green.Patient was programmed successfully with no ground pad.
 
Event or Problem Description
See section h, number 6, event problem and evaluation codes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AXONICS
Common Device Name
NEUROSTIMULATOR
MDR Report Key10123473
Report Number3002968685-2020-00043
Device Sequence Number3573593
Product Code EZW
UDI-Device Identifier10810005340134
UDI-Public10810005340134
Combination Product (Y/N)N
Initial Reporter StateIL
PMA/510(K) Number
P180046
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/01/2020
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 Date08/11/2021
Device Model Number1701
Device Catalogue Number1701
Device Lot NumberAK1M301001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2020
Initial Date Received by Manufacturer 05/08/2020
Supplement Date Received by Manufacturer05/08/2020
Initial Report FDA Received Date06/05/2020
Supplement Report FDA Received Date07/01/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-