FDA Adverse Event
Injury
Summary report: N
LD CV EZTRK 2 BP IS1 4543 90CM US
MDR report key: 1043047
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33604
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- February 18, 2008
- Report Date
- February 18, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWP
- 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 | LD CV EZTRK 2 BP IS1 4543 90CM US | IMPLANTABLE LEAD | LWP | CARDIAC PACEMAKERS, INC | 4543 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention | THE DEVICE 4457/506829 WAS IMPLANTED 27-JUN-2006| THE DEVICE 4470/509321 WAS IMPLANTED 27-JUN-2006| THE DEVICE H120/106266 WAS IMPLANTED 13-JUN-2007 |