FDA Adverse Event
Injury
Summary report: N
FLEXTEND II
MDR report key: 3913500
·
Received July 3, 2014
Report
- Report Number
- 2124215-2014-13052
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- June 10, 2014
- Report Date
- June 10, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS PRODUCT IS NOT EXPECTED TO BE RETURNED. 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 HAD DISLODGED. THE PHYSICIAN OPTED TO EXPLANT THIS RA LEAD AND SUCCESSFULLY REPLACED IT WITH A NEW ONE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RA LEAD IS NO LONGER IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390707 | FLEXTEND II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | F162| 0282| 4096| 4097 |