FDA Adverse Event
Malfunction
Summary report: N
VISTA DDD PULSE GENERATOR
MDR report key: 69000
·
Received January 9, 1997
Report
- Report Number
- 2124215-1997-00160
- Event Type
- Malfunction
- Date Received
- January 9, 1997
- Date of Event
- August 21, 1996
- Report Date
- August 21, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THE PROGRAMMER COULD NOT COMMUNICATE WITH THIS IMPLANTABLE PULSE GENERATOR (IPG) AFTER DEFIBRILLATION THRESHOLD TESTING AT THE IMPLANT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE IPG CONTINUED TO AV SEQUENTIALLY PACE AT THE PROGRAMMED LOWER RATE LIMIT OF 70 PPM.
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 | 54 YR | Other | THE DEVICE 1715/210033 WAS IMPLANTED 28-DEC-1993| THE DEVICE 4269/238017 WAS IMPLANTED 11-MAR-1996| THE DEVICE 4269/234342 WAS IMPLANTED 11-MAR-1996| THE DEVICE 0074/200039 WAS IMPLANTED 28-DEC-1993 |