FDA Adverse Event
Death
Summary report: N
EDWARDS PERICARDIAL PATCH
MDR report key: 1661184
·
Received April 18, 2010
Report
- Report Number
- 2015691-2010-13130
- Event Type
- Death
- Date Received
- April 18, 2010
- Date of Event
- September 25, 2009
- Report Date
- March 18, 2010
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DXZ
- PMA / PMN Number
- K833763
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED; (B) (6). INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER VIA FAX (ON 03/19/2010 AND 03/26/2010) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER IMPLANT DURATION OF APPROXIMATELY ZERO DAYS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDWARDS PERICARDIAL PATCH | PATCH | DXZ | EDWARDS LIFESCIENCES | 4700 | R-08H1771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death |