FDA Adverse Event
Malfunction
Summary report: N
SYMPHONY
MDR report key: 2151529
·
Received June 24, 2011
Report
- Report Number
- 9610579-2011-00066
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- May 5, 2005
- Report Date
- June 9, 2011
- Manufacturer
- SORIN CRM
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED 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. THE USER REPORTEDLY FAILED TO OBTAIN ATRIAL LEAD IMPEDANCE MEASUREMENTS THAT DAY. ALL OTHER ROUTINE TESTS COULD BE COMPLETED, INCLUDING ATRIAL THRESHOLD TEST AND ATRIAL SENSITIVITY TEST, AND NORMAL OPERATION OF THE PACEMAKER WAS OBSERVED (THE IMPLANT MEMORIES COULD BE READ PROPERLY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYMPHONY | NVZ | SORIN CRM | SYMPHONY DR 2550 | S060309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |