FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2041736
·
Received April 6, 2011
Report
- Report Number
- 2124215-2011-01492
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- January 12, 2011
- Report Date
- January 12, 2011
- 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
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AT MAXIMUM OUTPUTS FOR AN UNSPECIFIED AMOUNT OF TIME. A LEAD REVISION PROCEDURE WAS PERFORMED WERE THE RATE SENSE PORTION OF THIS LEAD WAS SURGICALLY ABANDONED AND A NEW RATE SENSE RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Life Threatening| R | (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4) |