FDA Adverse Event
Malfunction
Summary report: N
VIGOR DDD PULSE GENERATOR
MDR report key: 73898
·
Received January 16, 1997
Report
- Report Number
- 2124215-1997-00464
- Event Type
- Malfunction
- Date Received
- January 16, 1997
- Date of Event
- April 1, 1996
- Report Date
- October 11, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) IS EXHIBITING HIGH PACING THRESHOLDS IN THE VENTRICLE AND THAT THE THRESHOLDS HAD RISEN ABRUPTLY. WHEN THE IPG WAS PROGRAMMED TO THE UNIPOLAR MODE FOR TESTING, THE PHYSICIAN INDICATED THERE WAS 'NO IMPEDANCE READING'.
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 |