FDA Adverse Event
Injury
Summary report: N
VISTA DDD PULSE GENERATOR
MDR report key: 69063
·
Received January 9, 1997
Report
- Report Number
- 2124215-1997-00223
- Event Type
- Injury
- Date Received
- January 9, 1997
- Date of Event
- August 21, 1996
- Report Date
- August 30, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXHIBITING INTERMITTENT SENSING AND A MAGNET RATE THAT CHANGED FROM 98 TO 83 IN 24 HOURS AND DISPLAYED THE ELECTIVE REPLACEMENT TIME (ERT) INDICATOR. IMPLANT DATE-7/3/92 EXPLANT DATE-8/21/96 TOTAL IMPLANT TIME-49.6MONTHS CPI MINIMUM LONGEVITY AT NOMINAL SETTINGS WITH A 500 OHM LEAD IS 42 MONTHS. CPI DOES NOT KNOW THE IMPLANT PARAMETERS OR THE LEAD RESISTANCE THROUGHOUT THE IMPLANT LIFE OF THE SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISTA DDD PULSE GENERATOR Implant | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS | 0941 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |