FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2051752
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-03692
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- February 23, 2011
- Report Date
- February 23, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION IS EXPECTED AT THIS TIME OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE OUR INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM EXPLANT DUE TO INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT DUE TO THE EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |