FDA Adverse Event
Malfunction
Summary report: N
REPLY 200
MDR report key: 4427237
·
Received January 16, 2015
Report
- Report Number
- 1000165971-2015-00025
- Event Type
- Malfunction
- Date Received
- January 16, 2015
- Date of Event
- December 23, 2014
- Report Date
- December 23, 2014
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
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
Description of Event or Problem · 1
THE PHYSICIAN REPORTED A CONNECTION PROBLEM IN THE ATRIAL CHANNEL DURING THE IMPLANT ATTEMPT.
Description of Event or Problem · 1
THE PHYSICIAN REPORTED A CONNECTION PROBLEM IN THE ATRIAL CHANNEL DURING THE IMPLANT ATTEMPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39461 | REPLY 200 | NVZ | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | REPLY 200 DR | S0046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |