FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1952744
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23778
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 8, 2009
- Report Date
- December 3, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. TECHNICAL SERVICES (TS) DISCUSSED PERFORMING ISOMETRICS AND POCKET MANIPULATION AS WELL AS AN X-RAY TO DETERMINE THE CAUSE OF THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS SURGICALLY CAPPED. THERE WAS NO VISABLE FRACTURE OR INTERITY BREAKDOWN NOTED ON FLUOROSCOPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | 1861| 0148| 4470| E110 |