FDA Adverse Event
Death
Summary report: N
CAPSUREFIX
MDR report key: 1013451
·
Received March 10, 2008
Report
- Report Number
- 2649622-2008-00897
- Event Type
- Death
- Date Received
- March 10, 2008
- Date of Event
- May 18, 2007
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5068 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death | P1501DR IMPLANTABLE PULSE GENERATOR| 5068 IMPLANTABLE PACING LEAD |