FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1951995
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23149
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- November 29, 2010
- Report Date
- December 9, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
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Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CHRONIC RIGHT ATRIAL (RA) LEAD WAS SURGICALLY CAPPED DUE TO UNSPECIFIED PRODUCT PERFORMANCE ISSUE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION INDICATES THAT THIS LEAD WAS FRACTURED AT THE SUBCLAVIAN REGION. THE CLINICAL OBSERVATIONS INCLUDED FAILURE TO CAPTURE AND HIGH IMPEDANCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | 4469| 0184| H217| 4047| 0180 |