AXONICS
Report
- Report Number
- 2124215-2025-90727
- Event Type
- Malfunction
- Date Received
- December 12, 2025
- Date of Event
- October 1, 2025
- Report Date
- January 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
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006. UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(4). BLOCK H11: INVESTIGATION DETAILS: THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. A DEVICE WAS NOT RETURNED RESULTING IN AN INABILITY TO ANALYZE THE DEVICE AND IDENTIFY IF A MALFUNCTION OCCURRED. BASED ON THE INFORMATION AVAILABLE, IT CANNOT BE CONFIRMED WHAT THE CAUSE WAS. BASED ON THE DHR, THE DEVICE WAS CONFIRMED TO MEET SPECIFICATIONS PRIOR TO SHIPMENT THEREFORE CONCLUDING MANUFACTURING WAS NOT RELATED TO THE REPORTED EVENT. IF THE FURTHER INFORMATION IS RECEIVED THE INVESTIGATION WILL BE RE-OPENED. WITHOUT A RETURNED PRODUCT AVAILABLE FOR ANALYSIS AND BASED ON THIS INVESTIGATION, A CLEAR PROBABLE CAUSE FOR THE EVENT CANNOT BE ESTABLISHED; THEREFORE, THE CONCLUSION CODE OF CAUSE NOT ESTABLISHED HAS BEEN CHOSEN. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006. UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(4).
IT WAS REPORTED THE PATIENT HAD THEIR TINED LEAD AND NEUROSTIMULATOR EXPLANTED DUE TO HIGH IMPEDANCE. INITIALLY, THE PATIENT STATED THEY BELIEVED THEIR LEAD CAME LOOSE IN THEIR BODY. DUE TO THIS, THEIR REMOTE WAS NOT CONNECTING, AND THEY COULD NOT PROVE THEIR IMPLANT WAS MRI SAFE. THE PHYSICIAN STATED THE X-RAY WAS COMPLETED AND THERE WAS NO SIGN OF LEAD MIGRATION, CONCLUDED IT MUST BE A FRACTURE NOT VISIBLE IN THE IMAGE. THE PATIENT WAS DOING WELL AND NOT IN ANY DISCOMFORT. AN IMPEDANCE CHECK SHOWED ALL FOUR CONTACTS WERE HIGH. THE PATIENT HAD THEIR DEVICE OFF PRIOR TO THE EXPLANT PROCEDURE. THE ENTIRE SYSTEM WAS REMOVED WITH NO ABANDONED LEADS PRESENT. IT WAS CONFIRMED WITH FLUOROSCOPY THE EXPLANTED LEAD AND NEUROSTIMULATOR WAS EVALUATED AS INTACT. THE PATIENT WILL NOT BE RE-IMPLANTED WITH A NEW SYSTEM AND WILL EXPLORE OTHER OPTIONS WITH THEIR PHYSICIAN. THERE IS NO FURTHER INFORMATION AVAILABLE FOR THIS PATIENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT NOTED THAT THEY BELIEVED THEIR LEAD CAME LOOSE IN THEIR BODY. DUE TO THIS, THEIR REMOTE WAS NOT CONNECTING. THE PATIENT WAS CONCERNED THAT A MAGNETIC RESONANCE IMAGING (MRI) WOULDN'T BE SAFE, SO AN X-RAY WAS COMPLETED AND THERE WAS NO SIGN OF LEAD MIGRATION. THE PHYSICIAN THOUGHT A FRACTURE MIGHT HAVE OCCURRED AND WAS NOT VISIBLE IN THE IMAGING. THE PATIENT WAS DOING WELL AND NOT IN ANY DISCOMFORT. AN IMPEDANCE CHECK SHOWED ALL FOUR CONTACTS WERE HIGH. THE PATIENT HAD THEIR DEVICE OFF PRIOR TO THE EXPLANT PROCEDURE. THE ENTIRE SYSTEM WAS REMOVED WITH NO ABANDONED LEADS PRESENT. IT WAS CONFIRMED WITH FLUOROSCOPY THE EXPLANTED LEAD AND NEUROSTIMULATOR WAS EVALUATED AS INTACT. THE PATIENT WILL NOT BE RE-IMPLANTED WITH A NEW SYSTEM AND WILL EXPLORE OTHER OPTIONS WITH THEIR PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2759315 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 4101 | AX1T015799 | 10810005340455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | Required Intervention| H | TINED LEAD, 1201, AL1KA21941. |