FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK
MDR report key: 1253640
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-40487
- Event Type
- Malfunction
- Date Received
- November 11, 2008
- Date of Event
- September 12, 2008
- Report Date
- September 12, 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 | EASYTRAK | IMPLANTABLE LEAD | LWP | CARDIAC PACEMAKERS, INC | 4538 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other | THE DEVICE 0144/334910 WAS IMPLANTED 25-MAY-2000| THE DEVICE 1851/304755 WAS IMPLANTED 25-MAY-2000| THE DEVICE 6481 015738 WAS USED DURING THE EVENT.| THE DEVICE H170/500433 WAS IMPLANTED 15-JAN-2004 |