FDA Adverse Event
Injury
Summary report: N
EASYTRAK 3
MDR report key: 1042141
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34502
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 15, 2008
- Report Date
- March 15, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 3 | IMPLANTABLE LEAD | LWP | CARDIAC PACEMAKERS, INC | 4549 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | THE DEVICE 0185/128396 WAS IMPLANTED 26-SEP-2005| THE DEVICE 4472/411273 WAS IMPLANTED 10-MAY-2004| THE DEVICE 4538/150929 WAS IMPLANTED 21-JUL-2004| THE DEVICE 4543/135942 WAS IMPLANTED 15-MAR-2008| THE DEVICE H177/280966 WAS IMPLANTED 26-SEP-2005| THE DEVICE H217/710582 WAS IMPLANTED 23-JAN-2008 |