FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE G
MDR report key: 1043133
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33521
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- January 22, 2008
- Report Date
- February 12, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 | 0184 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | THE DEVICE 0184/143292 WAS IMPLANTED 13-FEB-2008| THE DEVICE T135/948833 WAS IMPLANTED 31-OCT-2007 |