FDA Adverse Event
Injury
Summary report: N
FLEXTEND II
MDR report key: 2913185
·
Received January 14, 2013
Report
- Report Number
- 2124215-2012-16496
- Event Type
- Injury
- Date Received
- January 14, 2013
- Date of Event
- December 10, 2012
- Report Date
- January 9, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.
Additional Manufacturer Narrative · 1
A PROCEDURE TOOK PLACE AND THIS LEAD WAS SUCCESSFULLY REPOSITIONED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD HAD DISLODGED AND LOSS OF CAPTURE WAS NOTED. A LEAD REVISION HAS BEEN PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19719 | FLEXTEND II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |