FDA Adverse Event
Malfunction
Summary report: N
ESPRIT
MDR report key: 3748265
·
Received January 24, 2014
Report
- Report Number
- 1000165971-2014-00034
- Event Type
- Malfunction
- Date Received
- January 24, 2014
- Date of Event
- December 19, 2013
- Report Date
- January 17, 2014
- Manufacturer
- SORIN GROUP ITALIA S.R.L.
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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
THE PHYSICIAN REPORTED THAT DURING THE IMPLANT OF THE SUBJECT DEVICE DIFFICULTIES WERE ENCOUNTERED WHEN CONNECTING THE A TRIAL LEAD. ANOTHER PACEMAKER WS SUBSEQUENTLY IMPLANTED INSTEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55620 | ESPRIT | NVZ | SORIN GROUP ITALIA S.R.L. | ESPRIT D | 2627 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |