FDA Adverse Event
Malfunction
Summary report: N
REPLY
MDR report key: 1960329
·
Received December 15, 2010
Report
- Report Number
- 1000165971-2010-01027
- Event Type
- Malfunction
- Date Received
- December 15, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 9, 2010
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DECEMBER (B)(4) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED 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
REPORTEDLY, THE VENTRICULAR LEAD IMPEDANCE CURVE RECORDED IN DEVICE MEMORY SHOWED HIGH IMPEDANCE (>3KOHM). HOWEVER, DURING THE LATEST FOLLOW UP ON (B)(6) 2010, NORMAL MEASUREMENT WAS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLY | NVZ | SORIN BIOMEDICA CRM S.R.L. | REPLY VDR | 2355 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |