FDA Adverse Event
Injury
Summary report: N
FLEXTEND II
MDR report key: 3053653
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05291
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- January 1, 2013
- Report Date
- March 28, 2013
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVN
- PMA / PMN Number
- NOTAPVD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, NO RETURN OF PRODUCT IS INTENDED. 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 ATRIAL LEAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS REMOVED AND NOT REPLACED AS THE PATIENT IS IN ATRIAL FIBRILLATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156820 | FLEXTEND II | IMPLANTABLE LEAD | NVN | GUIDANT PUERTO RICO BV | 4097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| L| R | 0950| 0465| (B)(4)| 1283| 4285 |