FDA Adverse Event
Malfunction
Summary report: N
VIGOR DDD PULSE GENERATOR
MDR report key: 74065
·
Received January 16, 1997
Report
- Report Number
- 2124215-1997-00622
- Event Type
- Malfunction
- Date Received
- January 16, 1997
- Date of Event
- October 29, 1996
- Report Date
- October 29, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS FOUND TO HAVE THE OUTPUT VOLTAGE REGULATION FEATURE ON OFF. THE REGULATION FEATURE WAS PROGRAMMED ON AND ADDITIONAL INTERROGATION INDICATED THAT THE OUTPUT VOLTAGE REGULATION REMAINS ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIGOR DDD PULSE GENERATOR Implant | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS | 0950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |