FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3211374
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08432
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 8, 2013
- Report Date
- May 6, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
UPON ADDITIONAL INFORMATION, THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS FRACTURED WHICH RESULTED IN THE PATIENTS BRADYCARDIA DUE TO LACK OF PACING. THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311599 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4459 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |