ECOIN PERIPHERAL NEUROSTIMULATOR
Report
- Report Number
- 3010878085-2026-00002
- Event Type
- Injury
- Date Received
- January 12, 2026
- Date of Event
- November 11, 2025
- Report Date
- January 30, 2026
- Manufacturer
- VALENCIA TECHNOLOGIES CORPORATION
- Product Code
- QPT
- PMA / PMN Number
- P200036
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
THE ECOIN DOES NOT EXPOSE THE PATIENT TO TITANIUM. THE ECOIN HAS A TITANIUM CASE AND TOP COVER WHICH ARE COMPLETELY ENCLOSED IN SILICONE RUBBER. THE ECOIN EXPOSES THE PATIENT TO SILICONE RUBBER AND PLATINUM. THE ECOIN DEVICE IS USED TO TREAT URGENCY URINARY INCONTINENCE. THE ALLEGED ALLERGIC REACTION COULD NOT BE CONFIRMED AS THE INITIAL REPORTER ASKED TO REMAIN CONFIDENTIAL AND PRODUCT INFORMATION WAS NOT PROVIDED. VALENCIA TECHNOLOGIES IS UNABLE TO CONFIRM WITH THE DOCTOR HOW IT WAS DETERMINED THAT THE PATIENT'S RESPONSE WAS AN ALLERGIC REACTION OR IF ANY MEDICAL INTERVENTION WAS REQUIRED. A REVIEW OF THE DEVICE HISTORY FILE COULD NOT BE PERFORMED AS PRODUCT INFORMATION WAS NOT PROVIDED. BASED ON THE AVAILABLE INFORMATION, NO MANUFACTURING OR PERFORMANCE RELATED ISSUES WERE IDENTIFIED WITH THE ECOIN DEVICE. THE COMPLAINT IS EVALUATED AS AN ALLEGED ALLERGIC PATIENT REACTION WITHOUT CONFIRMED DEVICE MALFUNCTION.
THE ECOIN DEVICE IS USED TO TREAT URGENCY URINARY INCONTINENCE. THE ALLEGED ALLERGIC REACTION COULD NOT BE CONFIRMED AS THE INITIAL REPORTER ASKED TO REMAIN CONFIDENTIAL AND PRODUCT INFORMATION WAS NOT PROVIDED. VALENCIA TECHNOLOGIES IS UNABLE TO CONFIRM WITH THE DOCTOR HOW IT WAS DETERMINED THAT THE PATIENT'S RESPONSE WAS AN ALLERGIC REACTION OR IF ANY MEDICAL INTERVENTION WAS REQUIRED. A REVIEW OF THE DEVICE HISTORY FILE COULD NOT BE PERFORMED AS PRODUCT INFORMATION WAS NOT PROVIDED. BASED ON THE AVAILABLE INFORMATION, NO MANUFACTURING OR PERFORMANCE RELATED ISSUES WERE IDENTIFIED WITH THE ECOIN DEVICE. THE COMPLAINT IS EVALUATED AS AN ALLEGED ALLERGIC PATIENT REACTION WITHOUT CONFIRMED DEVICE MALFUNCTION.
ON DECEMBER 12, 2025, VALENCIA TECHNOLOGIES WAS NOTIFIED THAT MW5179176, WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. THE FOLLOWING INFORMATION WAS PROVIDED IN MW5179176: "REP REPORTED THEY SPOKE WITH DR. (B)(6) ABOUT THIS CASE AND DR. (B)(6) SAID THAT THEY WERE SURE THIS WAS A CASE OF ALLERGIC REACTION AND NOT INFECTION. REP ALSO NOTED THAT ALTHOUGH THEY'RE SAYING IT'S A SILICONE ALLERGY, REP BELIEVES IT COULD BE TITANIUM, OR METAL. REP SAID A COUPLE OF HCPS INCLUDING DR. (B)(6) NOTED THAT THEY SAW SIMILAR ALLERGIC REACTIONS WITH THE ECOIN TRIAL, SO REP THINKS IT COULD BE THE METAL." THE INITIAL REPORTER ASKED TO REMAIN CONFIDENTIAL. THEREFORE, PATIENT INFORMATION, PRODUCT INFORMATION, AND FURTHER INFORMATION REGARDING THE REPORTED ISSUE COULD NOT BE OBTAINED.
ON DECEMBER 12, 2025, VALENCIA TECHNOLOGIES WAS NOTIFIED THAT MW5179176, WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. THE FOLLOWING INFORMATION WAS PROVIDED IN MW5179176: "REP REPORTED THEY SPOKE WITH DR. (B)(6) ABOUT THIS CASE AND DR. (B)(6) SAID THAT THEY WERE SURE THIS WAS A CASE OF ALLERGIC REACTION AND NOT INFECTION. REP ALSO NOTED THAT ALTHOUGH THEY'RE SAYING IT'S A SILICONE ALLERGY, REP BELIEVES IT COULD BE TITANIUM, OR METAL. REP SAID A COUPLE OF HCPS INCLUDING DR. (B) (6) NOTED THAT THEY SAW SIMILAR ALLERGIC REACTIONS WITH THE ECOIN TRIAL, SO REP THINKS IT COULD BE THE METAL." THE INITIAL REPORTER ASKED TO REMAIN CONFIDENTIAL. THEREFORE, PATIENT INFORMATION, PRODUCT INFORMATION, AND FURTHER INFORMATION REGARDING THE REPORTED ISSUE COULD NOT BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 407339 | ECOIN PERIPHERAL NEUROSTIMULATOR | ECOIN UUI | QPT | VALENCIA TECHNOLOGIES CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |