FDA Adverse Event
Injury
Summary report: N
DIAMOND 3
MDR report key: 1072921
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03676
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- April 30, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DXY
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIAMOND 3 | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC PUERTO RICO, INC. | 840 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |