FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1946245
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-21709
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- October 14, 2010
- Report Date
- November 4, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- 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.
Additional Manufacturer Narrative · 1
THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
WE RECEIVED ADDITIONAL INFORMATION INDICATING THIS SYSTEM HAS BEEN EXPLANTED DUE TO THE PATIENT INFECTION. NO ADVERSE PATIENT EFFECTS WERE EXPERIENCED DURING THE EXPLANT PROCEDURE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT IS SCHEDULED TO BE EXPLANTED DUE TO A PATIENT INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention | 4538| 4457| 1270| 4591| 4469| 4193| H120 |