FDA Adverse Event
Injury
Summary report: N
ATTAIN ACCESS
MDR report key: 1072612
·
Received July 10, 2008
Report
- Report Number
- 9612164-2008-00003
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- May 23, 2008
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- LWP
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN ACCESS | LEFT HEART DELIVERY SYSTEM | LWP | MEDTRONIC IRELAND | 6218A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |