AXONICS
Report
- Report Number
- 2124215-2025-38423
- Event Type
- Injury
- Date Received
- June 19, 2025
- Date of Event
- January 1, 2025
- Report Date
- January 5, 2026
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340141
- PMA / PMN Number
- P180046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IMAGING SHOWED THE LEAD HAD MIGRATED, LIKELY DUE TO THE CAR ACCIDENT. THE REPORTED COMPLAINT WAS CONFIRMED. SUPPLEMENTAL BEING SUBMITTED TO ADD TO (B5) SUMMARY.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006. THIS REPORT IS REPORT IS BEING SUBMITTED TO CORRECT THE SERIAL NUMBER FIELD (D4) ON SECTION D, SUSPECT MEDICAL DEVICE.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IMAGING SHOWED THE LEAD HAD MIGRATED, LIKELY DUE TO THE CAR ACCIDENT. THE REPORTED COMPLAINT WAS CONFIRMED.
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006 THIS REPORT IS REPORT IS BEING SUBMITTED TO CORRECT THE IMPACT CODING SECTION H6.
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR EXPERIENCED A FALL RESULTING IN A LEAD MIGRATION AND URINARY INCONTINENCE SYMPTOMS. THE MIGRATION WAS CONFIRMED WITH AN X-RAY. THE OLD LEAD WAS REMOVED, AND A NEW LEAD WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR EXPERIENCED A FALL IN (B)(6) 2025, RESULTING IN A LEAD MIGRATION. THE MIGRATION WAS CONFIRMED WITH AN X-RAY IN (B)(6) 2025. THE OLD LEAD WAS REMOVED, AND A NEW LEAD WAS PLACED ON (B)(6), 2025. THERE WERE NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR EXPERIENCED A FALL RESULTING IN A LEAD MIGRATION. THE MIGRATION WAS CONFIRMED WITH AN X-RAY. THE OLD LEAD WAS REMOVED, AND A NEW LEAD WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR EXPERIENCED A FALL RESULTING IN A LEAD MIGRATION. THE MIGRATION WAS CONFIRMED WITH AN X-RAY. THE OLD LEAD WAS REMOVED, AND A NEW LEAD WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR EXPERIENCED A FALL RESULTING IN A LEAD MIGRATION. THE MIGRATION WAS CONFIRMED WITH AN X-RAY. THE OLD LEAD WAS REMOVED, AND A NEW LEAD WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 747807 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1201 | AL1S401784 | 10810005340141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Hospitalization| R| O |