FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE G
MDR report key: 1042695
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33950
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- February 26, 2008
- Report Date
- February 26, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE G | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0175 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | THE DEVICE 4137/244581 WAS IMPLANTED 22-JAN-2008| THE DEVICE 4456/471432 WAS IMPLANTED 26-FEB-2008| THE DEVICE 4457/533135 WAS IMPLANTED 26-FEB-2008| THE DEVICE T180/210616 WAS IMPLANTED 22-JAN-2008 |