FDA Adverse Event
Injury
Summary report: N
ENDOTAK ENDURANCE EZ
MDR report key: 1041605
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-31938
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- October 20, 2006
- Report Date
- February 6, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- 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 | ENDOTAK ENDURANCE EZ | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0154 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | THE DEVICE 4470/572668 WAS IMPLANTED 06-FEB-2008| THE DEVICE T125/109809 WAS IMPLANTED 29-NOV-2004| THE DEVICE 0185/191447 WAS IMPLANTED 06-FEB-2008| THE DEVICE 4549/161144 WAS IMPLANTED 06-FEB-2008| THE DEVICE 4472/201434 WAS IMPLANTED 21-AUG-2001| THE DEVICE H210/216861 WAS IMPLANTED 06-FEB-2008 |