FDA Adverse Event
Malfunction
Summary report: N
IFORIA 5 VR-T DX PROMRI DF-1
MDR report key: 11943019
·
Received June 4, 2021
Report
- Report Number
- 1028232-2021-03064
- Event Type
- Malfunction
- Date Received
- June 4, 2021
- Date of Event
- May 20, 2021
- Report Date
- May 21, 2021
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- LWS
- PMA / PMN Number
- P050023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN MARCH 2021. THE PREMATURE BATTERY DEPLETION COULD BE CONFIRMED DURING ANALYSIS.
Description of Event or Problem · 1
AFTER AN IMPLANTATION PERIOD OF APPROX. 60 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE ERI STATUS. THE ICD WAS EXPLANTED. THIS DEVICE IS AFFECTED BY THE FIELD SAFETY NOTICE BIO-LQC, PUBLISHED ON (B)(6) 2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834393 | IFORIA 5 VR-T DX PROMRI DF-1 | ICD | LWS | BIOTRONIK SE & CO. KG | 390123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |