FDA Adverse Event
Injury
Summary report: N
FINELINE II EZ
MDR report key: 1041694
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34937
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 29, 2008
- Report Date
- March 29, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II EZ | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4469 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 97 YR | Required Intervention | THE DEVICE 1298/200196 WAS IMPLANTED 22-MAR-2005| THE DEVICE 4469/437411 WAS IMPLANTED 22-MAR-2005 |