FDA Adverse Event
Injury
Summary report: N
VISTA DDD PULSE GENERATOR
MDR report key: 93987
·
Received March 6, 1997
Report
- Report Number
- 2124215-1997-00821
- Event Type
- Injury
- Date Received
- March 6, 1997
- Date of Event
- November 26, 1996
- Report Date
- January 6, 1997
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED BECAUSE IT EXHIBITED EARLY BATTERY DEPLETION. THE ATRIAL BIPOLAR LEAD (4271) WAS REMOVED FROM SERVICE DUE TO INTERMITTANT LOSS OF CAPTURE.
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 1230/403058 WAS IMPLANTED 20-DEC-1996| THE DEVICE 4271/010854 WAS IMPLANTED 15-AUG-1994| THE DEVICE 4262/066690 WAS IMPLANTED 15-AUG-1994 |