FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1042560
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34094
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 4, 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 | 30 YR | Required Intervention | THE DEVICE T165/ WAS IMPLANTED| THE DEVICE 1861/238257 WAS IMPLANTED 22-JAN-2003| THE DEVICE 4470/339685 WAS IMPLANTED 22-JAN-2003| THE DEVICE T165/133848 WAS IMPLANTED 04-MAR-2008| THE DEVICE 0148/ WAS IMPLANTED |