AXONICS
Report
- Report Number
- 2124215-2025-50507
- Event Type
- Malfunction
- Date Received
- July 28, 2025
- Date of Event
- July 8, 2025
- Report Date
- September 17, 2025
- Manufacturer
- AXONICS MODULATION TECHNOLOGIES, INC.
- Product Code
- EZW
- UDI-DI
- 10810005340141
- PMA / PMN Number
- P180046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006 THIS REPORT IS BEING FILED FOR A CORRECTION TO FIELD (B5) INCIDENT DESCRIPTION.
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 B5 SECTION IS IMPACTED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED MORE FECAL INCONTINENCE EPISODES IN THE PAST SEVERAL MONTHS. REPROGRAMMING AND STIMULATION HOLIDAY WAS ATTEMPTED. THE IMPEDANCES HAVE GRADUALLY INCREASED TO YELLOW IMPEDANCES OVERTIME AS WELL. THE PATIENT HAD THEIR TINED LEAD REVISED ON (B)(6) 2025. THE OLD TINED LEAD WAS DISCARDED. THE CLINICAL SPECIALIST WILL CALL THE PATIENT TO CHECK IN WITH THEM. THE CLINICAL SPECIALIST UPDATED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AFTER THE REVISION ON (B)(6) 2025 DUE TO PAIN ON THE LEFT SIDE, BUT NO PAIN AT THE INS SITE. THE PATIENT'S FECAL INCONTINENCE SYMPTOMS IMPROVED. THE PHYSICIAN TURNED OFF THE DEVICE TO SEE IF THE PAIN GOES AWAY. THE CLINICAL SPECIALIST TRIED TO CALL FOR AN UPDATE AND TO HELP THE PATIENT TURN THE DEVICE BACK ON BUT HAS NOT RECEIVED A CALL BACK. THE CLINICAL SPECIALIST SAID THEY STILL HAVE NOT HEARD FROM THE PATIENT, BUT THEY WOULD CHECK WITH THE PHYSICIAN TO SEE IF THEY HEARD BACK. THE CLINICAL SPECIALIST CHECKED BACK WITH THE PHYSICIAN, AND THEY HAVE NOT HEARD FROM THE PATIENT, SO THE PHYSICIAN AND CLINICAL SPECIALIST ARE ASSUMING IT IS A GOOD THING.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED MORE FECAL INCONTINENCE EPISODES IN THE PAST SEVERAL MONTHS. REPROGRAMMING AND STIMULATION HOLIDAY WAS ATTEMPTED. THE IMPEDANCES HAVE GRADUALLY INCREASED TO YELLOW IMPEDANCES OVERTIME AS WELL. THE PATIENT HAD THEIR TINED LEAD REVISED ON (B)(6) 2025. THE OLD TINED LEAD WAS DISCARDED. THE CLINICAL SPECIALIST WILL CALL THE PATIENT TO CHECK IN WITH THEM.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED MORE FECAL INCONTINENCE EPISODES IN THE PAST SEVERAL MONTHS. REPROGRAMMING AND STIMULATION HOLIDAY WAS ATTEMPTED. THE IMPEDANCES HAVE GRADUALLY INCREASED TO YELLOW IMPEDANCES OVERTIME AS WELL. THE PATIENT HAD THEIR TINED LEAD REVISED ON (B)(6) 2025. THE OLD TINED LEAD WAS DISCARDED. THE CLINICAL SPECIALIST WILL CALL THE PATIENT TO CHECK IN WITH THEM. THE CLINICAL SPECIALIST UPDATED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AFTER THE REVISION ON (B)(6) 2025 DUE TO PAIN ON THE LEFT SIDE, BUT NO PAIN AT THE INS SITE. THE PATIENT'S FECAL INCONTINENCE SYMPTOMS IMPROVED. THE PHYSICIAN TURNED OFF THE DEVICE TO SEE IF THE PAIN GOES AWAY. THE CLINICAL SPECIALIST TRIED TO CALL FOR AN UPDATE AND TO HELP THE PATIENT TURN THE DEVICE BACK ON BUT HAS NOT RECEIVED A CALL BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1508709 | AXONICS | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | AXONICS MODULATION TECHNOLOGIES, INC. | 1201 | AL1M731244 | 10810005340141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention |