BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 24064209 · Received January 13, 2026

    Report

    Report Number
    2124215-2026-02343
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 1, 2025
    Report Date
    February 26, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRODUCT CODE: ADDITIONAL PRODUCT CODE QON. BLOCK G4: PREMARKET / 510(K) #: ADDITIONAL PREMARKET / 510(K) # P190006. BLOCK H11: INVESTIGATION DETAILS: THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. BASED ON THE INFORMATION PROVIDED, THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. SINCE THE INVESTIGATION FINDINGS DO NOT CLEARLY CONFIRM THE PRESENCE OR ABSENCE OF THE REPORTED PROBLEM WITH THE DEVICE, THE INVESTIGATION CONCLUSION CODE SELECTED FOR THIS COMPLAINT IS UNABLE TO EXCLUDE DEVICE PROBLEM. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.

    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 THE PATIENT HAD SURGERY TO REVISE THEIR NEUROSTIMULATOR. INITIALLY, THE PATIENT NEEDED AN MRI DUE TO A BRAIN INJURY FROM A CAR ACCIDENT. THE PHYSICIAN SUSPECTED THE LEAD MAY HAVE BEEN BROKEN FROM THE ACCIDENT. THE PATIENT HAD MULTIPLE DIAGNOSTIC TESTS, SUCH AS A CT SCAN, BUT CANNOT RECALL IF THE PHYSICIAN LOOKED AT OPERATING ROOM SAID ANYTHING ABOUT THE CONDITION OF THE LEAD. THE PATIENT PLANNED TO HAVE A DEVICE REVISION, BUT THEY WANTED TO HAVE THE MRI BEFORE THAT. THE PATIENT HAD THEIR DEVICE IN HIBERNATION MODE, AND THE REMOTE CONTROL DID NOT CONNECT. THE PATIENT WAS ADVISED THEY WOULD NEED TO CHARGE THEIR IMPLANT TO GET THE REMOTE TO CONNECT AND DO AN MRI READINESS CHECK TO DETERMINE THE SAFETY OF THEIR DEVICE. THERE WERE NO REPORTS FROM THE PHYSICIAN ABOUT A BROKEN OR FRACTURED LEAD. THE TINED LEAD WAS NOT REVISED, THE PATIENT'S SYMPTOMS WERE FINE, AND THEY ONLY DID THE INS SWAP. THE PATIENT IS DOING GREAT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD SURGERY TO REVISE THEIR NEUROSTIMULATOR. INITIALLY, THE PATIENT NEEDED AN MRI DUE TO A BRAIN INJURY FROM A CAR ACCIDENT. THE PHYSICIAN SUSPECTED THE LEAD MAY HAVE BEEN BROKEN FROM THE ACCIDENT. THE PATIENT HAD MULTIPLE DIAGNOSTIC TESTS, SUCH AS A CT SCAN, BUT CANNOT RECALL IF THE PHYSICIAN LOOKED AT OR SAID ANYTHING ABOUT THE CONDITION OF THE LEAD. THE PATIENT PLANNED TO HAVE A DEVICE REVISION, BUT THEY WANTED TO HAVE THE MRI BEFORE THAT. THE PATIENT HAD THEIR DEVICE IN HIBERNATION MODE, AND THE REMOTE CONTROL DID NOT CONNECT. THE PATIENT WAS ADVISED THEY WOULD NEED TO CHARGE THEIR IMPLANT TO GET THE REMOTE TO CONNECT AND DO AN MRI READINESS CHECK TO DETERMINE THE SAFETY OF THEIR DEVICE. THERE WERE NO REPORTS FROM THE PHYSICIAN ABOUT A BROKEN OR FRACTURED LEAD. THE TINED LEAD WAS NOT REVISED, THE PATIENT'S SYMPTOMS WERE FINE, AND THEY ONLY DID THE INS SWAP. THE PATIENT IS DOING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311341 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 AX1H170702 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Hospitalization| R