FDA Adverse Event
Injury
Summary report: N
SYMPHONY
MDR report key: 3781490
·
Received April 30, 2014
Report
- Report Number
- 1000165971-2014-00235
- Event Type
- Injury
- Date Received
- April 30, 2014
- Date of Event
- February 13, 2014
- Report Date
- April 2, 2014
- Manufacturer
- SORIN CRM
- Product Code
- NVZ
- PMA / PMN Number
- PP950029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTEDLY, RECOMMENDED REPLACEMENT TIME (RRT) REACHED ON (B)(6) 2013. THE DEVICE WAS EXPLANTED ON (B)(6) 2014 (DEVICE IS NOT AVAILABLE FOR ANALYSIS).
Description of Event or Problem · 1
REPORTEDLY, THE DEVICE HAD REACHED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2013. THE DEVICE WAS EXPLANTED ON (B)(6) 2014; IT HAS NOT BEEN RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260633 | SYMPHONY | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | SORIN CRM | SYMPHONY DR 2550 | M060428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |