FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1041625
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-31904
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 27, 2004
- Report Date
- January 21, 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 | 0157 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other | THE DEVICE 1280/535857 WAS IMPLANTED 21-MAY-2002| THE DEVICE 4034/306658 WAS IMPLANTED 21-MAY-2002| THE DEVICE T135/932442 WAS IMPLANTED 27-FEB-2004| THE DEVICE 4087/112940 WAS IMPLANTED 21-MAY-2002 |