FDA Adverse Event
Injury
Summary report: N
30MAY200CAPSURE SP NOVUS
MDR report key: 1072445
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03390
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- September 28, 2007
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 30MAY200CAPSURE SP NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4092 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention | 4592 IMPLANTABLE PACING LEAD| KDR601 IMPLANTABLE PULSE GENERATOR |