MAUDE Adverse Event Report: AXONICS MODULATION TECHNOLOGIES, INC. AXONICS; NEUROSTIMULATOR

Model Number	1701
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); Therapeutic Response, Decreased (2271)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending device return for evaluation.
Event or Problem Description
Patient was implanted with a pne lead on (b)(6) 2020.When patient left the hospital, the patient could not feel the stimulation and went back.The nurse saw an impedance error.The nurse replaced the trial stimulator, ground cable, and basic trial cable and this appeared to have resolved the issue.The next day, the issue reoccurred and the patient returned to the hospital.The doctor was unable to resolve the issue.On (b)(6)2020, the representative and doctor met with the patient and the representative was able to confirm an impedance error on their clinician programmer.The representative checked the connection to the trial stimulator and connection between the pne lead and basic trial cable, but results remained the same.The representative replaced the ground pad, but no changes.As the issue was unable to be resolved, the doctor decided to explant the pne lead.Per representative, only the basic trial cable is available for return.
Event or Problem Description
See section h, number 6, event problem and evaluation codes and section h, number 10, additional manufacturer narrative.

• Brand Name: AXONICS
• Common Device Name: NEUROSTIMULATOR
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology drive; irvine CA
• MDR Report Key: 10039477
• Report Number: 3002968685-2020-00039
• Device Sequence Number: 2812738
• Product Code: EZW
• UDI-Device Identifier: 10810005340134
• UDI-Public: 10810005340134
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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 Model Number: 1701
• Device Catalogue Number: 1701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 04/14/2020; 04/14/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 06/05/2020; 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1