FDA Adverse Event
Death
Summary report: N
ENDOTAK C
MDR report key: 683272
·
Received November 7, 2003
Report
- Report Number
- 2124215-2003-05929
- Event Type
- Death
- Date Received
- November 7, 2003
- Date of Event
- August 6, 2003
- Report Date
- August 6, 2003
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- 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 C | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS, INC | 0064 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Death |