FDA Adverse Event
Injury
Summary report: N
THE GUARDIAN SYSTEM
MDR report key: 21819212
·
Received April 10, 2025
Report
- Report Number
- 3017374019-2025-00002
- Event Type
- Injury
- Date Received
- April 10, 2025
- Date of Event
- October 28, 2022
- Report Date
- April 11, 2025
- Manufacturer
- AVERTIX MEDICAL INC.
- Product Code
- QBI
- PMA / PMN Number
- P150009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT WAS IMPLANTED WITH A GUARDIAN SYSTEM ON (B)(6) 2022. PATIENT WAS SEEN BY PHYSICIAN POST IMPLANT; IT WAS DETERMINED THE PATIENT HAD A POCKET INFECTION. THE PHYSICIAN MADE THE DECISION TO HAVE THE PATIENT EXPLANTED. EXPLANT WAS PERFORMED ON (B)(6) 2022. THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE EXPLANT. THIS MDR IS BEING FILED RETROACTIVELY TO SATISFY AN OBSERVATION CREATED DURING AN FDA INSPECTION WHICH WAS PERFORMED ON 11-FEB-2022 THROUGH 19-MAR-2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1239730 | THE GUARDIAN SYSTEM | GUARDIAN | QBI | AVERTIX MEDICAL INC. | AMSG3-E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Hospitalization| R |