FDA Adverse Event
Injury
Summary report: N
ENDOTAK DSP
MDR report key: 1042253
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34403
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 13, 2008
- Report Date
- March 13, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z1144/1145
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK DSP | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0125 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | THE DEVICE 1763/800950 WAS IMPLANTED 16-OCT-1996| THE DEVICE 1860/126400 WAS IMPLANTED 07-APR-2003| THE DEVICE T135/948627 WAS IMPLANTED 19-MAR-2008 |