FDA Adverse Event
Injury
Summary report: N
VISTA DDD PULSE GENERATOR
MDR report key: 94298
·
Received March 6, 1997
Report
- Report Number
- 2124215-1997-01090
- Event Type
- Injury
- Date Received
- March 6, 1997
- Date of Event
- October 10, 1994
- Report Date
- January 22, 1997
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR WAS EXPLANTED FOR EROSION.
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 | 83 YR | Required Intervention | THE DEVICE 1705/664620 WAS IMPLANTED 23-JUN-1994| THE DEVICE 0041/224927 WAS IMPLANTED 23-JUN-1994| THE DEVICE 4320/018257 WAS IMPLANTED 23-JUN-1994| THE DEVICE 0041/224925 WAS IMPLANTED 23-JUN-1994| THE DEVICE 4262/067398 WAS IMPLANTED 29-JUN-1994| THE DEVICE 4269/213142 WAS IMPLANTED 29-JUN-1994| THE DEVICE 4320/022420 WAS IMPLANTED 23-MAY-1994 |