FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1953662
·
Received January 10, 2011
Report
- Report Number
- 2124215-2010-23920
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- December 8, 2010
- Report Date
- December 13, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS IS CURRENTLY ON-GOING.
Additional Manufacturer Narrative · 1
AS OF TODAY, THIS PRODUCT HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION INDICATES THAT THIS PRODUCT WAS RETURNED FOR LABORATORY ANALYSIS.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE THIS RIGHT VENTRICULAR (RV) LEAD WAS NOT USED. IT WAS ALLEGED THAT THE LEAD WAS NOT WORKING AS THERE WAS NO SENSING OR CAPTURE AT 10 VOLTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A DIFFERENT PACE/SENSE LEAD WAS SUCCESSFULLY PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |