FDA Adverse Event
Malfunction
Summary report: N
LD CV EZTRK 2 BP IS1 4543 90CM US
MDR report key: 1042760
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33875
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 26, 2008
- Report Date
- February 26, 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 | 75 YR | Other | THE DEVICE 4137/245382 WAS IMPLANTED 27-FEB-2008| THE DEVICE 6481 308539 WAS USED DURING THE EVENT.| THE DEVICE 6949 LFJ053 WAS USED DURING THE EVENT.| THE DEVICE H170/504650 WAS IMPLANTED 27-APR-2005 |