FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1041540
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-31985
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- September 12, 2007
- Report Date
- March 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 | 0148 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | THE DEVICE 4538/150536 WAS IMPLANTED 30-DEC-2003| THE DEVICE H177/101062 WAS IMPLANTED 29-APR-2004| THE DEVICE H217/715146 WAS IMPLANTED 24-MAR-2008 |