FDA Adverse Event
Injury
Summary report: N
SELECT SECURE
MDR report key: 1050063
·
Received May 22, 2008
Report
- Report Number
- 2649622-2008-03237
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- April 2, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELECT SECURE | IMPLANTABLE PACING LEAD | NVN | MEDTRONIC PUERTO RICO, INC. | 3830 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention | 1290 IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD |