FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1041527
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-32000
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- October 19, 2007
- Report Date
- January 8, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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 1861/202519 WAS IMPLANTED 21-DEC-2000| THE DEVICE 4480/ WAS IMPLANTED| THE DEVICE T167/112443 WAS IMPLANTED 19-OCT-2007 |