FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1042515
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34134
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 5, 2008
- Report Date
- March 5, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0148 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention | THE DEVICE 4439/819036 WAS IMPLANTED 15-MAR-1999| THE DEVICE 4086/230859 WAS IMPLANTED 16-AUG-2006| THE DEVICE 4034/206039 WAS IMPLANTED 15-MAR-1999| THE DEVICE T125/117370 WAS IMPLANTED 16-AUG-2006 |