FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3912470
·
Received July 3, 2014
Report
- Report Number
- 2124215-2014-13183
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- January 1, 2014
- Report Date
- June 2, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISLODGED. THE PHYSICIAN WAS UNABLE TO REPOSITION OR REMOVE THIS LEAD. THIS RA LEAD WAS THEN SURGICALLY ABANDONED AND WAS REPLACED WITH A NEW ONE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391307 | FINELINE II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4479 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| L| R | 4136| K063| 4479 |