FDA Adverse Event
Injury
Summary report: N
VISTA DDD PULSE GENERATOR
MDR report key: 73781
·
Received January 16, 1997
Report
- Report Number
- 2124215-1997-00587
- Event Type
- Injury
- Date Received
- January 16, 1997
- Date of Event
- October 22, 1996
- Report Date
- October 29, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED DUE TO EARLY BATTERY DEPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISTA DDD PULSE GENERATOR Implant | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS | 0940 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | THE DEVICE 4269/262128 WAS IMPLANTED 17-DEC-1996| THE DEVICE 4261/209191 WAS IMPLANTED 17-DEC-1996| THE DEVICE 4269/039954 WAS IMPLANTED 14-OCT-1993| THE DEVICE 0950/296250 WAS IMPLANTED 17-DEC-1996| THE DEVICE 0950/298249 WAS IMPLANTED 23-OCT-1996| THE DEVICE 4261/055865 WAS IMPLANTED 14-OCT-1993 |