FDA Adverse Event
Injury
Summary report: N
VIGOR DDD PULSE GENERATOR
MDR report key: 74055
·
Received January 16, 1997
Report
- Report Number
- 2124215-1997-00636
- Event Type
- Injury
- Date Received
- January 16, 1997
- Date of Event
- October 29, 1996
- Report Date
- October 30, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXHIBITING PREMATURE BATTERY DEPLETION. AN INVASIVE PROCEDURE WAS PERFORMED TO EXPLANT THE IPG. DURING THE PROCEDURE THE BIPOLAR LEAD, MODEL 4269, WAS REMOVED FROM SERVICE FOR 'NOT HAVING GOOD CAPTURE DUE TO THE LEAD BEING SLIGHTLY DISLODGED'.
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 0950/297120 WAS IMPLANTED 30-OCT-1996| THE DEVICE 4269/248300 WAS IMPLANTED 30-OCT-1996| THE DEVICE 4271/015806 WAS IMPLANTED 18-MAY-1995| THE DEVICE 4269/228674 WAS IMPLANTED 18-MAY-1995 |