BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 23935319 · Received December 31, 2025

    Report

    Report Number
    2124215-2025-93986
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    November 3, 2025
    Report Date
    January 30, 2026
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006. BLOCK H11: ADDITIONAL INFORMATION: BLOCK B5: INCIDENT DESCRIPTION.

    Additional Manufacturer Narrative · 0

    PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET/510(K) # (G4) - ADDITIONAL PREMARKET/510(K) # P190006.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE NEUROSTIMULATOR (INS) WAS UNABLE TO CONNECT THEIR DEVICE TO THE REMOTE. THE PATIENT TRIED MULTIPLE TIMES TO CONNECT THE REMOTE BUT ONLY OBSERVED THE LIGHTS BRIEFLY ILLUMINATING AND SHUTTING OFF. THE PATIENT FURTHER REPORTED CHARGING THEIR DEVICE EVERY TWO AND A HALF WEEKS AND CONSISTENTLY HEARING THE APPROPRIATE TONES. FOLLOWING A DEVICE CHARGE, THE PATIENT WAS STILL UNABLE TO CONNECT THE REMOTE TO THEIR INS. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED WITH A RECHARGE-FREE DEVICE TO ELIMINATE BURDEN FOR THE PATIENT. THE PATIENT IS DOING WELL POST-REVISION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE NEUROSTIMULATOR (INS) WAS UNABLE TO CONNECT THEIR DEVICE TO THE REMOTE. THE PATIENT TRIED MULTIPLE TIMES TO CONNECT THE REMOTE BUT ONLY OBSERVED THE LIGHTS BRIEFLY ILLUMINATING AND SHUTTING OFF. THE PATIENT FURTHER REPORTED CHARGING THEIR DEVICE EVERY TWO AND A HALF WEEKS AND CONSISTENTLY HEARING THE APPROPRIATE TONES. FOLLOWING A DEVICE CHARGE, THE PATIENT WAS STILL UNABLE TO CONNECT THE REMOTE TO THEIR INS. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED WITH A RECHARGE-FREE DEVICE TO ELIMINATE BURDEN FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564075 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Hospitalization| R