FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 2172878
·
Received July 22, 2011
Report
- Report Number
- 2124215-2011-10603
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 10, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS DAMAGED DURING THE COURSE OF THE EXTRACTION; THEREFORE THE LEAD WAS DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS EXPLANTED DUE TO INSULATION DAMAGE AND NOISE. THE NOISE WAS OVERSENSED RESULTING IN INTERMITTENT INHIBITION OF THERAPY. A REVIEW OF THE ELECTROGRAMS REVEALED NO INHIBITION FOR GREATER THAN TWO SECONDS. NO ADVERSE PATIENT EFFECTS WERE NOTED.
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 | 71 YR | 4457| 4086| 4137| 4456| S404| 1291 |