FDA Adverse Event
Injury
Summary report: N
VIGOR DDD PULSE GENERATOR
MDR report key: 94360
·
Received March 6, 1997
Report
- Report Number
- 2124215-1997-01146
- Event Type
- Injury
- Date Received
- March 6, 1997
- Date of Event
- January 30, 1997
- Report Date
- January 30, 1997
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR WAS EXHIBITING THE ELECTIVE REPLACEMENT PAST (ERP) INDICATOR DURING EVALUATION. THE ERP WAS CLEARED WITH A MEASURED BATTERY VOLTAGE OF 2.75V. THE PATIENT IS PACEMAKER DEPENDENT. THE PHYSICIAN ELECTED TO EXPLANT THE IPG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIGOR DDD PULSE GENERATOR Implant | IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS | 0950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention | THE DEVICE 1232/201045 WAS IMPLANTED 04-FEB-1997| THE DEVICE 4271/015858 WAS IMPLANTED 02-AUG-1995| THE DEVICE 4261/227243 WAS IMPLANTED 02-AUG-1995 |