FDA Adverse Event
Malfunction
Summary report: N
ITREVIA 5 DR-T DF4 PROMRI
MDR report key: 12054265
·
Received June 23, 2021
Report
- Report Number
- 1028232-2021-03562
- Event Type
- Malfunction
- Date Received
- June 23, 2021
- Date of Event
- June 12, 2021
- Report Date
- June 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 (B)(6) 2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 949415 | ITREVIA 5 DR-T DF4 PROMRI | ICD | MRM | BIOTRONIK SE & CO. KG | 392421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |