FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1072861
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03612
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- November 20, 2007
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5071 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other | 8042 IMPLANTABLE PULSE GENERATOR| 5524M IMPLANTABLE PACING LEAD| 5024M IMPLANTABLE PACING LEAD |