FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1953596
·
Received January 10, 2011
Report
- Report Number
- 2124215-2010-24266
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- December 12, 2010
- Report Date
- December 12, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EFFORTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A HIGH OUT OF RANGE PACING IMPEDANCES WERE NOTED WITH THIS RIGHT VENTRICULAR LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0157 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4) |