FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1254254
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-40860
- Event Type
- Injury
- Date Received
- November 11, 2008
- Date of Event
- September 24, 2008
- Report Date
- September 24, 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 | 0158 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | THE DEVICE 0181/112914 WAS IMPLANTED 24-SEP-2008| THE DEVICE 1860/121137 WAS IMPLANTED 31-DEC-2002| THE DEVICE E102/002564 WAS IMPLANTED 24-SEP-2008 |