FDA Adverse Event
Injury
Summary report: N
SYMPHONY
MDR report key: 1151367
·
Received September 3, 2008
Report
- Report Number
- 2182863-2008-00048
- Event Type
- Injury
- Date Received
- September 3, 2008
- Date of Event
- August 4, 2008
- Report Date
- September 2, 2008
- Manufacturer
- ELA MEDICAL, S.A.S.
- Product Code
- DXY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SINCE THE DEVICE WAS NOT RETURNED, THE PRODUCTION HISTORY AND STERILIZATION RECORDS WERE REVIEWED. THE RECORDS SHOWED THAT THE DEVICE WAS MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES.
Description of Event or Problem · 1
AFTER ALMOST 3 YEARS OF IMPLANTATION, THIS PACEMAKER WAS EXPLANTED DUE TO EROSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYMPHONY | CARDIAC PACEMAKER | DXY | ELA MEDICAL, S.A.S. | 2550 | S050808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |