FDA Adverse Event
Malfunction
Summary report: N
MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)
MDR report key: 24646434
·
Received March 19, 2026
Report
- Report Number
- 3012309950-2026-00013
- Event Type
- Malfunction
- Date Received
- March 19, 2026
- Date of Event
- February 17, 2026
- Report Date
- March 19, 2026
- Manufacturer
- MICROTRANSPONDER, INC.
- Product Code
- QPY
- UDI-DI
- 10810041430028
- PMA / PMN Number
- P210007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
SUBMISSION WAS DELAYED DUE TO ROUTINE ONSITE FDA INSPECTION.
Description of Event or Problem · 0
PATIENT IS NOT ABLE TO ACTIVATE THE IPG DURING AT HOME THERAPY SESSIONS USING THE MAGNET. TROUBLESHOOTING STEPS WERE PERFORMED. THE PATIENT IS USING A MAGNET THAT WAS NOT PROVIDED BY MTI TO ACTIVATE THE DEVICE AT HOME. DEVICE WILL CONTINUE TO BE MONITORED BY MICROTRANSPONDER AND THE THERAPIST. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 706910 | MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) | VIVISTIM® SYSTEM | QPY | MICROTRANSPONDER, INC. | 1001 | H5480 | 10810041430028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Unknown |