FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1042226
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34405
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 12, 2008
- Report Date
- March 12, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 0148 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | THE DEVICE 0148/ WAS IMPLANTED| THE DEVICE 4518/201858 WAS IMPLANTED 28-FEB-2003| THE DEVICE 6501 WAS USED DURING THE EVENT.| THE DEVICE H235/651625 WAS IMPLANTED 07-JUN-2007 |