FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2153404
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-06276
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- February 15, 2011
- Report Date
- April 8, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE ABANDONED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC; THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO CLAVICULAR CRUSH. THE ABANDONED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4471 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Required Intervention | 4470| 4471| S603 |