FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1042478
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34153
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 6, 2008
- Report Date
- March 6, 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 | 84 YR | Other | THE DEVICE 1861/257946 WAS IMPLANTED 16-APR-2004| THE DEVICE 4087/206154 WAS IMPLANTED 16-APR-2004 |