FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1042407
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34249
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 6, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0138 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | THE DEVICE 4543/105883 WAS IMPLANTED 22-FEB-2005| THE DEVICE M170/100081 WAS IMPLANTED 22-FEB-2005| THE DEVICE 4195/AAD004 WAS IMPLANTED| THE DEVICE 0181/109002 WAS IMPLANTED 01-MAR-2008| THE DEVICE H190/312416 WAS IMPLANTED 15-AUG-2006 |