FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE G
MDR report key: 1043151
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33484
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 13, 2008
- Report Date
- February 13, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 | 0185 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | THE DEVICE 6482 017081 WAS USED DURING THE EVENT.| THE DEVICE 4087/263509 WAS IMPLANTED 18-SEP-2006| THE DEVICE H210/204334 WAS IMPLANTED 21-SEP-2006| THE DEVICE 0721/100251 WAS IMPLANTED 21-SEP-2006 |