FDA Adverse Event
Injury
Summary report: N
FLEXTEND II
MDR report key: 2173769
·
Received July 24, 2011
Report
- Report Number
- 2124215-2011-10756
- Event Type
- Injury
- Date Received
- July 24, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 21, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTED SYSTEM WAS EXPLANTED DUE TO INFECTION. THE SYSTEM HAD BEEN IMPLANTED FOR APPROXIMATELY (B)(6) AND NO EXPLANTED PRODUCT IS INTENDED TO RETURNED. TO DATE, NO INFORMATION COMMUNICATED REGARDING FUTURE IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | (B)(4)| (B)(4)| (B)(4) |