FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 1013366
·
Received March 10, 2008
Report
- Report Number
- 2649622-2008-00968
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- June 15, 2007
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- INVALID DATA
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 | 75 YR | Other| R | KDR901 IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD |