FDA Adverse Event
Malfunction
Summary report: N
MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)
MDR report key: 23175694
·
Received September 29, 2025
Report
- Report Number
- 3012309950-2025-00005
- Event Type
- Malfunction
- Date Received
- September 29, 2025
- Date of Event
- August 29, 2025
- Report Date
- September 29, 2025
- Manufacturer
- MICROTRANSPONDER, INC.
- Product Code
- QPY
- PMA / PMN Number
- P210007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2025. DUE TO LOW LEAD IMPEDANCE, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY ON (B)(6) 2025. DURING THE SURGERY IT WAS DETERMINED THAT THE LEAD PIN WAS NOT FULLY INSERTED INTO THE IPG HEADER, WHICH WAS WHY THE LEAD HAD LOW IMPEDANCE. THE LEAD AND IPG WERE TESTED PRIOR TO CLOSURE AND THE LEAD IMPEDANCE WAS 3260 OHMS WHICH IS WITHIN NORMAL RANGE. DEVICE IS PERFORMING AS EXPECTED. NO DEVICES WERE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2145339 | MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) | VIVISTIM® SYSTEM | QPY | MICROTRANSPONDER, INC. | 3000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Other |