FDA Adverse Event
Injury
Summary report: N
MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)
MDR report key: 19994322
·
Received August 15, 2024
Report
- Report Number
- 3012309950-2024-00003
- Event Type
- Injury
- Date Received
- August 15, 2024
- Date of Event
- July 17, 2024
- Report Date
- August 15, 2024
- Manufacturer
- MICROTRANSPONDER, INC.
- Product Code
- QPY
- UDI-DI
- 10810041430028
- PMA / PMN Number
- P210007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
DURING PHYSICAL THERAPY, THE PATIENT EXPERIENCED HIGH LEAD IMPEDANCE WARNING OF > 10 KOHMS. THE PATIENT MET WITH THE SURGEON AND IT WAS RECOMMENDED THE SYSTEM OR DEVICE BE REPLACED. DURING THE SURGERY, THE SURGEON INSPECTED THE LEAD, THE LEAD APPEARED INTACT, AND NO CAUSE WAS FOUND TO CREATE THE HIGH IMPEDANCE. THE SURGEON UNSCREWED THE LEAD AND REATTACHED THE LEAD TO THE ORIGINALLY IMPLANTED IPG, THE IMPEDANCE WAS WITH IN NORMAL RANGE. AT THE SURGEON'S THE DISCREATION, THE IPG WAS REPLACED WITH A NEW DEVICE, THE INITIAL LEAD WAS LEFT IMPLANTED. THE IMPEDANCE MEASUREMENTS WERE PERFORMED AND WERE WITHIN RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1640016 | MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) | VIVISTIM® SYSTEM | QPY | MICROTRANSPONDER, INC. | 1001 | 10810041430028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Male | Other |