FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND
MDR report key: 1946163
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20905
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- September 22, 2010
- Report Date
- October 14, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LEAD REMAINS IMPLANTED. 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 ATRIAL LEAD DISPLAYED HIGH IMPEDANCE MEASUREMENTS ONE DAY AFTER THE DEVICE REPLACEMENT PROCEDURE. ANOTHER MANUFACTURES FIELD REPRESENTATIVE PERFORMED TESTING AND COULD NOT REPRODUCE THE HIGH IMPEDANCE MEASUREMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | MISMATCH| H175| 4518| 4087| 0158 |