FDA Adverse Event
Malfunction
Summary report: N
VISTA DDD PULSE GENERATOR
MDR report key: 68937
·
Received January 9, 1997
Report
- Report Number
- 2124215-1997-00096
- Event Type
- Malfunction
- Date Received
- January 9, 1997
- Date of Event
- August 13, 1996
- Report Date
- August 13, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXHIBITING SIGNS OF PREMATURE BATTERY DEPLETION AFTER BEING IMPLANTED FOR 8 MONTHS.
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 | 78 YR | Other | THE DEVICE 4312/060973 WAS IMPLANTED 31-JAN-1996| THE DEVICE 1725/251495 WAS IMPLANTED 31-JAN-1996| THE DEVICE 0041/213614 WAS IMPLANTED 31-JAN-1996| THE DEVICE 4312/060972 WAS IMPLANTED 31-JAN-1996| THE DEVICE 0041/221263 WAS IMPLANTED 31-JAN-1996| THE DEVICE 4269/242861 WAS IMPLANTED 09-JAN-1995| THE DEVICE 4269/240505 WAS IMPLANTED 09-JAN-1995 |