FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2171529
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-10014
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 13, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS
- 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
SUBSEQUENTLY, ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THIS RV LEAD HAS BEEN TAKEN OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED FROM THE PROCEDURE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD HAS DISLODGED FROM ITS ORIGINAL IMPLANTED SITE. A FUTURE REVISION PROCEDURE HAS BEEN SCHEDULED TO REPOSITION THIS LEAD. NO OTHER ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | N118| 4518| 0184| 4086| T165| 4087 |