FDA Adverse Event
Malfunction
Summary report: N
VITA 2 DDDR
MDR report key: 372302
·
Received January 10, 2002
Report
- Report Number
- 6000095-2002-00001
- Event Type
- Malfunction
- Date Received
- January 10, 2002
- Manufacturer
- VITATRON MEDICAL B.V.
- Product Code
- DXY
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LOW P-WAVES; P-WAVES CONSISTENTLY DIFFERENT THAN WHAT ANALYZER READ. SUBSEQUENTLY TESTED OUT OF SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITA 2 DDDR | IMPLANTABLE PULSE GENERATOR | DXY | VITATRON MEDICAL B.V. | 830 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 000 | Other |