FDA Adverse Event
Malfunction
Summary report: N
SENSIA SR
MDR report key: 1072356
·
Received July 10, 2008
Report
- Report Number
- 6000094-2008-00345
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- May 2, 2008
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NVZ
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSIA SR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC S.A. | SESR01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Required Intervention |