FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK 3
MDR report key: 1042741
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33900
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 25, 2008
- Report Date
- February 25, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWP
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 3 | IMPLANTABLE LEAD | LWP | CARDIAC PACEMAKERS, INC | 4525 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | THE DEVICE 0185/173672 WAS IMPLANTED 25-FEB-2008| THE DEVICE 4470/565394 WAS IMPLANTED 25-FEB-2008| THE DEVICE 4518/330160 WAS IMPLANTED 25-FEB-2008| THE DEVICE 4525/161931 WAS IMPLANTED 25-FEB-2008| THE DEVICE H219/207588 WAS IMPLANTED 25-FEB-2008 |