FDA Adverse Event
Malfunction
Summary report: N
IFORIA 5 DR-T PROMRI DF4
MDR report key: 11874221
·
Received May 25, 2021
Report
- Report Number
- 1028232-2021-02811
- Event Type
- Malfunction
- Date Received
- May 25, 2021
- Date of Event
- March 18, 2021
- Report Date
- April 21, 2021
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- MRM
- 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
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO ERI STATUS APPROX. 55 MONTHS AFTER THE IMPLANTATION. PLEASE NOTE THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN MARCH 2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 777706 | IFORIA 5 DR-T PROMRI DF4 | ICD | MRM | BIOTRONIK SE & CO. KG | 390117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |