FDA Adverse Event
Malfunction
Summary report: N
THE GUARDIAN SYSTEM
MDR report key: 21834871
·
Received April 14, 2025
Report
- Report Number
- 3017374019-2025-00027
- Event Type
- Malfunction
- Date Received
- April 14, 2025
- Date of Event
- May 29, 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 NOT EXPLANTED. NO ANALYSIS POSSIBLE.
Description of Event or Problem · 0
PREMATURE ERI/EOS BATTERY PROBLEM. THIS DEVICE IS ONE OF 25 THAT EXPERIENCED THIS ISSUE. THIS MDR IS BEING FILED RETROACTIVELY AT THE REQUEST OF CDRH AND OII AFTER INSPECTION IN FEB OF 2025. AVERTIX CONDUCTED A RECALL/CORRECTION IN 2023 FOR THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1022827 | THE GUARDIAN SYSTEM | GUARDIAN | QBI | AVERTIX MEDICAL INC. | AMSG3-E | 121720V0209530000037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Female | Required Intervention |