FDA Adverse Event
Malfunction
Summary report: N
DA+ C SERIES SR
MDR report key: 1072178
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03321
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- February 19, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DXY
- Removal / Correction Number
- NI
- 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 | DA+ C SERIES SR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC PUERTO RICO, INC. | C20A1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other | ADSR01 IMPLANTABLE PULSE GENERATOR| ICF09B IMPLANTABLE PACING LEAD |