FDA Adverse Event
Death
Summary report: N
ELLIPSE VR, DF-4 CONNECTOR
MDR report key: 4130773
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16191
- Event Type
- Death
- Date Received
- September 30, 2014
- Date of Event
- July 2, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INFECTION AND CARDIOGENIC SHOCK. THE PATIENT EXPIRED THREE DAYS POST ADMISSION. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607615 | ELLIPSE VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1377-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death | 7122Q/58, BKB039569 |