FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3081054
·
Received April 26, 2013
Report
- Report Number
- 2124215-2013-06098
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 25, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO LEAD FRACTURE. THIS WAS NOTED BY THE PHYSICIAN DURING THE DEVICE CHANGE OUT. THIS LEAD WAS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182724 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| L| R | 4469| 0158| A155| E141| T165 |