FDA Adverse Event
Malfunction
Summary report: N
VISTA DDD PULSE GENERATOR
MDR report key: 69154
·
Received January 9, 1997
Report
- Report Number
- 2124215-1997-00314
- Event Type
- Malfunction
- Date Received
- January 9, 1997
- Date of Event
- September 22, 1996
- Report Date
- September 22, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT DURING THE REMOVAL OF A LEAD THAT WAS RECALLED BY ANOTHER MANUFACTURER, THIS IMPLANTABLE PULSE GENERATOR (IPG) REVERTED TO STAT 1-VVI MODE AFTER THE USE OF ELECTROCAUTERY. (STAT 1-VVI MODE IS A SPECIAL HIGH ENERGY MODE OF PULSE GENERATOR OPERATION.) CPI'S PHYSICIAN'S MANUAL FOR THE VISTA DDD PULSE GENERATOR RECOMMENDS USING CAUTION WHEN ELECTROCAUTERY IS NECESSARY ON A PATIENT WITH AN IPG.
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 | 81 YR | Other | THE DEVICE 0446/707388 WAS IMPLANTED 19-SEP-1996 |