FDA Adverse Event
Malfunction
Summary report: N
ESPRIT
MDR report key: 2033755
·
Received February 11, 2011
Report
- Report Number
- 1000165971-2011-00071
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- December 29, 2010
- Report Date
- January 27, 2011
- Manufacturer
- SORIN CRM S.R.L.
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FEBRUARY 11, 2011. 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 DEVICE INVOLVED IN THIS REPORT WAS INTERROGATED AFTER IMPLANTATION. THE BATTERY DATA WERE SHOWING AN IMPEDANCE HIGHER THAN EXPECTED AND A TIME TO ERI SHORTER THAN EXPECTED FOR A NEWLY IMPLANTED DEVICE. REPORTEDLY, ON THE NEXT DAY, BATTERY IMPEDANCE AND TIME TO ERI WERE BACK TO NORMAL VALUES FOR A NEWLY IMPLANTED DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESPRIT | NVZ | SORIN CRM S.R.L. | ESPRIT D | 2488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |