FDA Adverse Event
Injury
Summary report: N
VIGOR DDD PULSE GENERATOR
MDR report key: 69138
·
Received January 9, 1997
Report
- Report Number
- 2124215-1997-00298
- Event Type
- Injury
- Date Received
- January 9, 1997
- Date of Event
- August 19, 1996
- Report Date
- September 18, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR EROSION. CPI PHYSICIAN'S MANUAL 353504 004A PAGE 29 LIST EROSION AS AN ADVERSE EFFECT OF THIS IPG.
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 | 80 YR | Required Intervention | THE DEVICE 4161/016125 WAS IMPLANTED 25-SEP-1995| THE DEVICE 0950/295738 WAS IMPLANTED 19-AUG-1996| THE DEVICE 4171/001095 WAS IMPLANTED 25-SEP-1995 |