FDA Adverse Event
Malfunction
Summary report: N
REPLY
MDR report key: 2043263
·
Received February 25, 2011
Report
- Report Number
- 1000165971-2011-00089
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- February 2, 2011
- Report Date
- February 10, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FEB. 25, 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 PACEMAKER INVOLVED IN THIS REPORT WAS INTERROGATED ON (B)(6) 2011. NORMAL RATE WAS CONFIRMED. HOWEVER, REVIEW OF THE FILES SHOWED THAT PACING WAS DELIVERED AT UPPER-RATE (120 MIN-1) FOR LONG PERIOD OF TIME ON (B)(6) 2011 (DURING AN ATRIAL ARRHYTHMIA). THE PHYSICIAN REQUESTED AN EXPLANATION: WHY NO FALLBACK MODE SWITCH OCCURRED, AND WHY PACING AT UPPER-RATE WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLY | NVZ | SORIN C.R.M., S.R.L. | REPLY DR | 2320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |