BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 22810861 · Received August 14, 2025

    Report

    Report Number
    2124215-2025-56005
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    July 22, 2025
    Report Date
    March 5, 2026
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340455
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006. UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(4). THIS REPORT IS BEING FILED FOR A CORRECTION TO FIELD H6.

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRODUCT CODE: ADDITIONAL PRODUCT CODE QON. BLOCK G4: PREMARKET / 510(K) #: ADDITIONAL PREMARKET / 510(K) # P190006. UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(4). BLOCK H11: INVESTIGATION DETAILS: THE DEVICE WAS RETURNED FOR ANALYSIS. THIS INVESTIGATION IS ASSIGNED A MOST PROBABLE CONCLUSION CODE OF 'END OF LIFE PROBLEM IDENTIFIED'. THIS CONCLUSION WAS SELECTED BECAUSE THE REASON FOR PREMATURE DISCHARGE OF BATTERY WAS MOST LIKELY DETERMINED TO BE BATTERY REACHING END OF ITS USEFUL LIFE FROM THE ANALYSIS OF THE AVAILABLE INFORMATION. THE EVIDENCE FROM THE PRODUCT RECORD REVIEW DID NOT IDENTIFY A POTENTIAL PRODUCT QUALITY ISSUE OR NEW PATIENT HARM. THEREFORE, IT CAN BE CONCLUDED THAT BATTERY HAS REACHED END OF ITS USEFUL LIFE WAS THE MOST PROBABLE CAUSE OF THE COMPLAINT/EVENT. CORRECTION: BLOCK H6: IMPACT CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A REVISION SURGERY OF THEIR NEUROSTIMULATOR AND TINED LEAD. FROM INITIAL X-RAYS, IT APPEARED THE LEAD MAY HAVE NEVER BEEN IN A FORAMEN. THE PATIENT STATED THEY TRIED SEVERAL PROGRAMS AND HAD NEVER BEEN ABLE TO FEEL THE STIMULATION AND NEVER HAD SYMPTOM RELIEF. THE CLINICAL SPECIALIST (CS) LINKED TO THE PATIENT'S INS BEFORE THE REVISION SURGERY, AND IT SHOWED LESS THAN SIX MONTHS BEFORE THE END OF LIFE. THE PATIENT WAS ON MAXIMUM STIMULATION AS INDICATED BY THEIR REMOTE CONTROL, SO IT MAY BE EXPECTED. THE PHYSICIAN BELIEVED THE PATIENT'S PREMATURE INS BATTERY DEPLETION AND ZERO EFFICACY FOR THE PATIENT WERE DUE TO POOR PLACEMENT BY THE INITIAL IMPLANTER. THE CS WAS PRESENT AT THE REVISION SURGERY. THE PATIENT WAS IMPLANTED WITH A NEW SYSTEM. THE PHYSICIAN DOES NOT ALLOW THE CARE TEAM TO TAKE IMAGES OF THE X-RAY. THE PATIENT IS DOING GREAT. THEY REPORTED SYMPTOM RELIEF ALREADY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A REVISION SURGERY OF THEIR NEUROSTIMULATOR AND TINED LEAD. FROM INITIAL X-RAYS, IT APPEARED THE LEAD MAY HAVE NEVER BEEN IN A FORAMEN. THE PATIENT STATED THEY TRIED SEVERAL PROGRAMS AND HAD NEVER BEEN ABLE TO FEEL THE STIMULATION AND NEVER HAD SYMPTOM RELIEF. THE CLINICAL SPECIALIST (CS) LINKED TO THE PATIENT'S INS BEFORE THE REVISION SURGERY, AND IT SHOWED LESS THAN SIX MONTHS BEFORE THE END OF LIFE. THE PATIENT WAS ON MAXIMUM STIMULATION AS INDICATED BY THEIR REMOTE CONTROL, SO IT MAY BE EXPECTED. THE PHYSICIAN BELIEVED THE PATIENT'S PREMATURE INS BATTERY DEPLETION AND ZERO EFFICACY FOR THE PATIENT WERE DUE TO POOR PLACEMENT BY THE INITIAL IMPLANTER. THE CS WAS PRESENT AT THE REVISION SURGERY THE PATIENT WAS IMPLANTED WITH A NEW SYSTEM. THE PHYSICIAN DOES NOT ALLOW THE CARE TEAM TO TAKE IMAGES OF THE X-RAY. THE PATIENT IS DOING GREAT. THEY REPORTED SYMPTOM RELIEF ALREADY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A REVISION SURGERY OF THEIR NEUROSTIMULATOR AND TINED LEAD. FROM INITIAL X-RAYS, IT APPEARED THE LEAD MAY HAVE NEVER BEEN IN A FORAMEN. THE PATIENT STATED THEY TRIED SEVERAL PROGRAMS AND HAD NEVER BEEN ABLE TO FEEL THE STIMULATION AND NEVER HAD SYMPTOM RELIEF. THE CLINICAL SPECIALIST (CS) LINKED TO THE PATIENT'S INS BEFORE THE REVISION SURGERY, AND IT SHOWED LESS THAN SIX MONTHS BEFORE THE END OF LIFE. THE PATIENT WAS ON MAXIMUM STIMULATION AS INDICATED BY THEIR REMOTE CONTROL, SO IT MAY BE EXPECTED. THE PHYSICIAN BELIEVED THE PATIENT'S PREMATURE INS BATTERY DEPLETION AND ZERO EFFICACY FOR THE PATIENT WERE DUE TO POOR PLACEMENT BY THE INITIAL IMPLANTER. THE CS WAS PRESENT AT THE REVISION SURGERY THE PATIENT WAS IMPLANTED WITH A NEW SYSTEM. THE PHYSICIAN DOES NOT ALLOW THE CARE TEAM TO TAKE IMAGES OF THE X-RAY. THE PATIENT IS DOING GREAT. THEY REPORTED SYMPTOM RELIEF ALREADY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686806 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 4101 AX1T008729 10810005340455

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention TINED LEAD, 1201, (B)(6).