FDA Adverse Event
Injury
Summary report: N
REPLY
MDR report key: 1830975
·
Received September 7, 2010
Report
- Report Number
- 1000165971-2010-00884
- Event Type
- Injury
- Date Received
- September 7, 2010
- Date of Event
- August 18, 2010
- Report Date
- August 19, 2010
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SEPT 7, 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
CONNECTION ISSUES ASSOCIATED WITH THE VENTRICULAR CHANNEL DURING THE IMPLANTATION PROCEDURE; THEREFORE, THE DEVICE WAS NOT IMPLANTED. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED. THE PHYSICIAN HAS NOT WATCHED THE ASSOCIATED VIDEO POSTED ON THE COMPANY WEBSITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLY | NVZ | SORIN BIOMEDICA CRM S.R.L. | REPLY DR | 2450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |