FDA Adverse Event
Injury
Summary report: N
ENDOTAK ENDURANCE RX
MDR report key: 1042275
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34370
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 11, 2008
- Report Date
- March 11, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- 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 | ENDOTAK ENDURANCE RX | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0145 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | THE DEVICE 0185/181364 WAS IMPLANTED 11-MAR-2008| THE DEVICE H175/101386 WAS IMPLANTED 17-NOV-2003| THE DEVICE 4513/401242 WAS IMPLANTED 17-NOV-2003| THE DEVICE H215/708334 WAS IMPLANTED 11-MAR-2008 |