FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3771529
·
Received April 24, 2014
Report
- Report Number
- 2124215-2014-09080
- Event Type
- Injury
- Date Received
- April 24, 2014
- Date of Event
- March 20, 2013
- Report Date
- March 18, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 WAS DISLODGED AND MIGRATED. THIS RA LEAD WAS SURGICALLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS DISLODGED. THIS RA LEAD WAS SURGICALLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249364 | FINELINE II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| L| R | 4136| N119| 4592| 0158| 4480 |