FDA Adverse Event
Death
Summary report: N
CAPSUREFIX
MDR report key: 1050053
·
Received May 16, 2008
Report
- Report Number
- 2649622-2008-03230
- Event Type
- Death
- Date Received
- May 16, 2008
- Date of Event
- February 8, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4568 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other | 6945 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |