FDA Adverse Event
Malfunction
Summary report: N
VIGOR DDD PULSE GENERATOR
MDR report key: 94172
·
Received March 6, 1997
Report
- Report Number
- 2124215-1997-01001
- Event Type
- Malfunction
- Date Received
- March 6, 1997
- Date of Event
- December 23, 1996
- Report Date
- December 23, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXHIBITING NO OUTPUT IN THE BIPOLAR MODE. THE IPG WAS REPROGRAMMED TO UNIPOLAR AND IS FUNCTIONING APPROPRIATELY.
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 | UNKNOWN | Other | THE DEVICE 4285/204695 WAS IMPLANTED 20-MAY-1996| THE DEVICE 4293/200386 WAS IMPLANTED 20-MAY-1996 |