FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 4132267
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-14504
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- May 13, 2014
- Report Date
- July 21, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- 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 EXHIBITED PACING INHIBITION LEADING TO SYNCOPE. AN X-RAY SHOWED THE LEAD HAD MOVED. THE PHYSICIAN ELECTED TO REVISE THE LEAD. THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612620 | FINELINE II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| L| R | MISMATCH| 4469 |