FDA Adverse Event
Injury
Summary report: N
CAPSURE EPI
MDR report key: 1072566
·
Received July 10, 2008
Report
- Report Number
- 2182208-2008-00246
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- February 29, 2008
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- MO
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE EPI | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC, INC. | 4968 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention | 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4968 IMPLANTABLE PACING LEAD| 6721M IMPLANTABLE TACHY LEAD |