FDA Adverse Event
Malfunction
Summary report: N
SOLIA T 53
MDR report key: 22982505
·
Received September 5, 2025
Report
- Report Number
- 1028232-2025-04399
- Event Type
- Malfunction
- Date Received
- September 5, 2025
- Date of Event
- September 4, 2025
- Report Date
- September 10, 2025
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVN
- UDI-DI
- 04035479118280
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
COMBINATION PRODUCT: YES. 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.
Additional Manufacturer Narrative · 0
COMBINATION PRODUCT: YES.
Description of Event or Problem · 0
LEAD WAS CAPPED BECAUSE IT DISLODGED AND MIGRATED RESULTING IN NO CAPTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Description of Event or Problem · 0
LEAD WAS CAPPED BECAUSE IT DISLODGED AND MIGRATED RESULTING IN NOO CAPTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321396 | SOLIA T 53 | PACING LEAD | NVN | BIOTRONIK SE & CO. KG | 377180 | 04035479118280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male | Hospitalization |