FDA Adverse Event
Malfunction
Summary report: N
THE GUARDIAN SYSTEM
MDR report key: 21834874
·
Received April 14, 2025
Report
- Report Number
- 3017374019-2025-00028
- Event Type
- Malfunction
- Date Received
- April 14, 2025
- Date of Event
- June 6, 2024
- Report Date
- April 14, 2025
- Manufacturer
- AVERTIX MEDICAL INC.
- Product Code
- QBI
- PMA / PMN Number
- P150009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DEVICE WAS NOT EXPLANTED. THEREFORE NO ANALYSIS POSSIBLE.
Description of Event or Problem · 0
PREMATURE ERI/EOS FOR BATTERY. THIS DEVICE IS ONE OF 25 DEVICES THAT HAD THIS PROBLEM. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII AFTER AN INSPECTION IN FEB 2025. AVERTIX PERFORMED A RECALL/CORRECTION IN 2023 FOR THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1022830 | THE GUARDIAN SYSTEM | GUARDIAN | QBI | AVERTIX MEDICAL INC. | AMSG3-E | 011121V0210150000038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Required Intervention |