FDA Adverse Event
Injury
Summary report: N
LD CV EZTRK 2 BP IS1 4543 90CM US
MDR report key: 1043613
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33022
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- January 31, 2008
- Report Date
- January 31, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWP
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LD CV EZTRK 2 BP IS1 4543 90CM US | IMPLANTABLE LEAD | LWP | CARDIAC PACEMAKERS, INC | 4543 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | THE DEVICE 1190/125914 WAS IMPLANTED 01-JUL-2005| THE DEVICE 4087/241240 WAS IMPLANTED 01-JUL-2005| THE DEVICE 6481 032054 WAS USED DURING THE EVENT.| THE DEVICE T180/209226 WAS IMPLANTED 12-FEB-2007 |