FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 1072824
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03591
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- June 6, 2007
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6945 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | 7290CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB |