FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 2823127
·
Received November 7, 2012
Report
- Report Number
- 2124215-2012-13870
- Event Type
- Injury
- Date Received
- November 7, 2012
- Date of Event
- May 4, 2012
- Report Date
- May 4, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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
ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT TWIDDLED THEIR DEVICE AND THIS RIGHT ATRIAL (RA) LEAD, CAUSING THE LEAD TO BECOME DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED. IT WAS NOTED THAT THE LEAD WAS DISCARDED AFTER THE PROCEDURE. NO 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 | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| L| R | 0185| E110| 4470 |