FDA Adverse Event
Malfunction
Summary report: N
ATTAIN OTW
MDR report key: 1072030
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03441
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- October 8, 2007
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWP
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- MO
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN OTW | IMPLANTABLE PACING LEAD | LWP | MEDTRONIC PUERTO RICO, INC. | 4193 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other| R | 4470 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 7303 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |