ECOIN PERIPHERAL NEUROSTIMULATOR
Report
- Report Number
- 3010878085-2025-00006
- Event Type
- Injury
- Date Received
- November 17, 2025
- Date of Event
- October 15, 2025
- Report Date
- January 30, 2026
- Manufacturer
- VALENCIA TECHNOLOGIES CORPORATION
- Product Code
- QPT
- UDI-DI
- 00860007896903
- PMA / PMN Number
- P200036
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
POTENTIAL CAUSES OF CELLULITIS INCLUDE: THE PATIENT HAVING CO-MORBIDITIES, THE PATIENT PARTICIPATING IN ANY UNUSUAL/STRENUOUS ACTIVITY, OR EXPERIENCING ANY TRAUMA AT THE IMPLANT SITE. ALTHOUGH THE PATIENT DOES NOT HAVE ANY CONTRAINDICATING CONDITIONS, IT WAS NOTED THE PATIENT HAS MANY ALLERGIES. THE PATIENT'S PROGRAMMING FILE WAS REVIEWED AND THERE WERE NO RELATED ISSUES NOTED. THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE (502750) INCLUDING THE STERILE LOAD HISTORY REPORT (300-765) AND THE PROCEDURAL KIT LOT (300-992, R00470) AVAILABLE AT THE IMPLANTATION FACILITY WERE REVIEWED AND THERE WERE NO RELATED ISSUES FOUND. THE DEVICE ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. HOWEVER, FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED.
POTENTIAL CAUSES OF CELLULITIS INCLUDE: THE PATIENT HAVING CO-MORBIDITIES, THE PATIENT PARTICIPATING IN ANY UNUSUAL/STRENUOUS ACTIVITY, OR EXPERIENCING ANY TRAUMA AT THE IMPLANT SITE. ALTHOUGH THE PATIENT DOES NOT HAVE ANY CONTRAINDICATING CONDITIONS, IT WAS NOTED THE PATIENT HAS MANY ALLERGIES. THE PATIENT'S PROGRAMMING FILE WAS REVIEWED AND THERE WERE NO RELATED ISSUES NOTED. THE DEVICE HISTORY FILE FOR BOTH THE ECOIN DEVICE ((B)(6)) INCLUDING THE STERILE LOAD HISTORY REPORT (300-765) AND THE PROCEDURAL KIT LOT (300-992, R00470) AVAILABLE AT THE IMPLANTATION FACILITY WERE REVIEWED AND THERE WERE NO RELATED ISSUES FOUND. FAILURE ANALYSIS WAS NOT REQUIRED AS THE PATIENT DID NOT EXPERIENCE DISCOMFORT ASSOCIATED WITH STIMULATION. ADDITIONALLY, THE PATIENT HAD CO-MORBIDITIES WHICH MAY HAVE BEEN ASSOCIATED WITH THE DISCOMFORT REPORTED BY THE PATIENT. THE ECOIN DEVICE IS USED TO TREAT URGENCY URINARY INCONTINENCE. THE CAUSE OF THE REPORTED ISSUE IS UNKNOWN. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ON THE CAUSE OF THE REPORTED ISSUE. THEREFORE, THE ROOT CAUSE CODE WAS SELECTED AS UNABLE TO DETERMINE.
THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2024 AND THE DEVICE WAS ACTIVATED ON (B)(6) 2024 WITH AN AMPLITUDE SETTING OF 2 MA. THE EXECUTIVE TERRITORY MANAGER MET WITH THE PATIENT ON (B)(6) 2025 TO TURN OFF THE DEVICE DUE TO THE PATIENT FEELING SOME DISCOMFORT. AN ULTRASOUND WAS PERFORMED WHICH SHOWED INDURATION AND POSSIBLE CELLULITIS OF THE AREA. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 04, 2025. THE PATIENT WAS EXPERIENCING PAIN AROUND THE SITE OF THE ECOIN DEVICE. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025.
THE PATIENT WAS IMPLANTED WITH THE ECOIN DEVICE ON (B)(6) 2024 AND THE DEVICE WAS ACTIVATED ON (B)(6) 2024 WITH AN AMPLITUDE SETTING OF 2 MA. THE EXECUTIVE TERRITORY MANAGER MET WITH THE PATIENT ON (B)(6) 2025 TO TURN OFF THE DEVICE DUE TO THE PATIENT FEELING SOME DISCOMFORT. THE PATIENT DID NOT EXPERIENCE ANY DISCOMFORT WITH STIMULATION. AN ULTRASOUND WAS PERFORMED WHICH SHOWED INDURATION AND POSSIBLE CELLULITIS OF THE AREA. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 04, 2025. THE PATIENT WAS EXPERIENCING PAIN AROUND THE SITE OF THE ECOIN DEVICE. ANTIBIOTICS WERE PRESCRIBED. HOWEVER, IT DID NOT RESOLVE. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17274 | ECOIN PERIPHERAL NEUROSTIMULATOR | ECOIN UUI | QPT | VALENCIA TECHNOLOGIES CORPORATION | 1011-2447 | 00860007896903 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Required Intervention |