FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 2170332
·
Received July 20, 2011
Report
- Report Number
- 2124215-2011-09646
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- February 1, 2011
- Report Date
- June 1, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. 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 RIGHT VENTRICULAR (RV) NOISE WAS OVERSENSED, RESULTING IN APPROXIMATELY A TWO SECOND PAUSE IN PACING. THE NOISE WAS NOT REPRODUCEABLE AND ALL LEAD MEASUREMENTS WERE REPORTEDLY STABLE. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED AS A RESULT OF THE PAUSE IN PACING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | 4457| 1297| 4480 |