FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2780132
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-12007
- Event Type
- Injury
- Date Received
- October 10, 2012
- Date of Event
- September 3, 2012
- Report Date
- September 3, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE FOR THIS RIGHT VENTRICULAR (RV) LEAD, THE PATIENT COMPLAINED ABOUT NOT FEELING WELL. AN ECHOCARDIOGRAM WAS DONE AND SHOWED 2CM OF FLUID IN THE PERICARDIUM. A DRAIN WAS PLACED. THE PHYSICIAN HAD TRIED MULTIPLE POSITIONS TO GET GOOD RV SENSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |