FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 6027162
·
Received October 13, 2016
Report
- Report Number
- 2124215-2016-15140
- Event Type
- Injury
- Date Received
- October 13, 2016
- Date of Event
- August 26, 2016
- Report Date
- August 26, 2016
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- UDI-DI
- 00802526264993
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- 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 RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH PACING THRESHOLDS. IT WAS NOT DETERMINED IF THERE WAS LEAD ISSUE VERSUS EXIT BLOCK. THIS RA LEAD WAS SURGICALLY ABANDONED. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD REPRESENTATIVE INDICATES THAT THERE WAS NO OTHER CLINICAL OBSERVATION NOTED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678529 | FINELINE II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4470 | 00802526264993 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| L| R | 4470| 4471| 7741| L331| S603 |