FDA Adverse Event
Death
Summary report: N
LARGE EPICARDIAL PATCH LEAD
MDR report key: 683376
·
Received November 7, 2003
Report
- Report Number
- 2124215-2003-05820
- Event Type
- Death
- Date Received
- November 7, 2003
- Date of Event
- July 10, 2003
- Report Date
- July 10, 2003
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LARGE EPICARDIAL PATCH LEAD | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 0068 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Death |