FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 1072688
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03778
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- January 15, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6944 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other| R | 4194 IMPLANTABLE PACING LEAD| 7297 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5982 IMPLANTABLE PULSE GENERATOR |