FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2053250
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04269
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- March 2, 2011
- Report Date
- April 8, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED SEVERED. ONE COIL WAS IN TWO PIECES FROM ELECTRO-CAUTERY MELTING IT. ELECTRO-CAUTERY ALSO MELTED THE INSULATION. DRIED BODILY FLUID HAD ENTERED THROUGH THE ENTIRE LEAD LUMEN. THE ALLEGATION OF LEAD DISLODGEMENT COULD NOT BE REPLICATED IN ANALYSIS, HOWEVER TECHNICIANS CONFIRMED THERE WERE NO ANOMALIES FOUND WITH THE HELIX OF THE LEAD.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISLODGED POST IMPLANT. THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 285 MO | Life Threatening| R | S602| 4136| 4469| 4456 |