FDA Adverse Event
Malfunction
Summary report: N
REPLY
MDR report key: 2043271
·
Received February 25, 2011
Report
- Report Number
- 1000165971-2011-00090
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- February 10, 2011
- Report Date
- February 14, 2011
- Manufacturer
- SORIN 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
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
THE REPORTED EVENT WAS OBSERVED ON A FUNCTIONAL DEMO DEVICE. THE REST RATE WAS A PROGRAMMABLE PARAMETER AND OPERATIONAL WHEN THE DEVICE WAS PROGRAMMED IN AAIR PACING MODE, WHICH WAS UNEXPECTED BY THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLY | NVZ | SORIN C.R.M., S.R.L. | REPLY SR | 1111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |