FDA Adverse Event
Malfunction
Summary report: N
LD CV EZTRK 2 BP IS1 4543 90CM US
MDR report key: 1041643
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34997
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 31, 2008
- Report Date
- March 31, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LD CV EZTRK 2 BP IS1 4543 90CM US | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4543 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other | THE DEVICE 4554/162007 WAS IMPLANTED 31-MAR-2008| THE DEVICE H227/559107 WAS IMPLANTED 31-MAR-2008| THE DEVICE H177/506344 WAS IMPLANTED 17-MAR-2005| THE DEVICE 0184/110288 WAS IMPLANTED 17-MAR-2005 |