FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3053214
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05344
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 14, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 THE RIGHT ATRIAL (RA) LEAD DISLODGED. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SUCCESSFULLY REPOSITIONED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155324 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| L| R | 4087| S603| 4088 |