FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2162574
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-07801
- Event Type
- Injury
- Date Received
- July 14, 2011
- Date of Event
- April 19, 2011
- Report Date
- April 19, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD REMAINS IMPLANTED. IF FURTHER INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD BECAME DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINS ACTIVELY IMPLANTED. NO ADVERSE PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |