FDA Adverse Event
Malfunction
Summary report: N
SOLIA S 53
MDR report key: 8703460
·
Received June 17, 2019
Report
- Report Number
- 1028232-2019-02375
- Event Type
- Malfunction
- Date Received
- June 17, 2019
- Date of Event
- November 9, 2018
- Report Date
- May 22, 2019
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVN
- UDI-DI
- 04035479118266
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LEAD IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA OR THE LEAD ITSELF BECOME AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS LEAD DISLODGED APPROXIMATELY 40 DAYS AFTER THE IMPLANTATION AND WAS REPOSITIONED. THE LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499572 | SOLIA S 53 | PACING LEAD | NVN | BIOTRONIK SE & CO. KG | 377177 | 04035479118266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |