FDA Adverse Event
Malfunction
Summary report: N
FACIL
MDR report key: 1668808
·
Received April 9, 2010
Report
- Report Number
- 1000165971-2010-00641
- Event Type
- Malfunction
- Date Received
- April 9, 2010
- Date of Event
- April 1, 2010
- Report Date
- April 6, 2010
- Manufacturer
- SORIN BIOMEDICA C.R.M., S.R.L.
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER P950029. ANALYSIS IS PENDING.
Description of Event or Problem · 1
CONNECTION ISSUES ASSOCIATED WITH BOTH CHANNELS DURING THE IMPLANTATION PROCEDURE; THEREFORE, THE DEVICE WAS NOT IMPLANTED. THE PHYSICIAN HAS NOT WATCHED THE LEAD CONNECTION VIDEO POSTED ON THE COMPANY WEBSITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FACIL | NVZ | SORIN BIOMEDICA C.R.M., S.R.L. | FACIL DR | 2373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |