FDA Adverse Event
Malfunction
Summary report: N
REOCOR D
MDR report key: 20246660
·
Received September 18, 2024
Report
- Report Number
- 1028232-2024-04853
- Event Type
- Malfunction
- Date Received
- September 18, 2024
- Date of Event
- August 14, 2024
- Report Date
- March 2, 2026
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- OVJ
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN BASED ON AVAILABLE INFORMATION AT THE MOMENT. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.
Description of Event or Problem · 0
DEVICE FAILURE WAS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Description of Event or Problem · 0
DEVICE FAILURE WAS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573914 | REOCOR D | EXTERNAL PACEMAKER | OVJ | BIOTRONIK SE & CO. KG | 365529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |