FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 4150810
·
Received October 8, 2014
Report
- Report Number
- 2124215-2014-17870
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- August 28, 2014
- Report Date
- August 28, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. THE PATIENT HAD STAPHYLOCOCCUS INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632401 | FINELINE II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Hospitalization| L| R | 4136| 4047| K173| K062| 4457 |