FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK 3
MDR report key: 1041773
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34876
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 28, 2008
- Report Date
- March 26, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 3 | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4524 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other | THE DEVICE M175/100046 WAS IMPLANTED 25-OCT-2004| THE DEVICE 0166/102009 WAS IMPLANTED 25-OCT-2004| THE DEVICE 4096/109839 WAS IMPLANTED 25-OCT-2004| THE DEVICE P106/000119 WAS IMPLANTED 28-FEB-2008 |