FDA Adverse Event
Injury
Summary report: N
INSYNC III
MDR report key: 1072436
·
Received July 10, 2008
Report
- Report Number
- 6000094-2008-00288
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- September 18, 2007
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- RI
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC III | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | 8042 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other | 4194 IMPLANTABLE PACING LEAD| 5076 X 2 IMPLANTABLE PACING LEADS |