FDA Adverse Event
Malfunction
Summary report: N
INLEXA 3 VR-T DF4 PROMRI
MDR report key: 11874238
·
Received May 25, 2021
Report
- Report Number
- 1028232-2021-02814
- Event Type
- Malfunction
- Date Received
- May 25, 2021
- Date of Event
- April 19, 2021
- Report Date
- April 22, 2021
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- MRM
- 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. 38 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 |
|---|---|---|---|---|---|---|---|
| 778477 | INLEXA 3 VR-T DF4 PROMRI | MRM | BIOTRONIK SE & CO. KG | 404704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |