FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3040649
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-00487
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- January 2, 2013
- Report Date
- January 2, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- 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 DISLODGEMENT. THIS PATIENT UNDERWENT A REVISION PROCEDURE; HOWEVER, THE LEAD WAS UNABLE TO BE REPOSITIONED AS THE PATIENT'S LEFT SIDE WAS OCCLUDED. THE LEAD WAS SURGICALLY CAPPED AND ABANDONED AND THE SYSTEM WAS MOVED TO THE OTHER SIDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142574 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| L| R | T125| 0185| 4087 |