FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 3211069
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08653
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 30, 2013
- Report Date
- April 30, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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 DURING A RECENT DEVICE CHANGE OUT PROCEDURE IT WAS NOTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED OUT-OF-RANGE (OOR) IMPEDANCES OF GREATER THAN 3000 OHMS. THE PHYSICIAN ELECTED TO ELECTRICALLY PROGRAM THE DEVICE TO VVIR. THE LEAD REMAINS IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310934 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | A155| 4518| 4472| 0184| H215| N164 |