FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 1072354
·
Received July 10, 2008
Report
- Report Number
- 2182208-2008-00243
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- May 13, 2008
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | PERMANENT LEAD EXTENSION | LWS | MEDTRONIC, INC. | 6984M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | 4568 IMPLANTABLE PACING LEAD| SDR303 IMPLANTABLE PULSE GENERATOR |