FDA Adverse Event
Malfunction
Summary report: N
MICROTHIN P-II BIPOLAR PULSE GENERATOR
MDR report key: 74050
·
Received January 16, 1997
Report
- Report Number
- 2124215-1997-00631
- Event Type
- Malfunction
- Date Received
- January 16, 1997
- Date of Event
- November 7, 1996
- Report Date
- November 7, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED RECEIVED A PHONE CALL CONCERNING THIS IMPLANTABLE PULSE GENERATOR (IPG). THE CALLER FELT THAT THE IPG MAY HAVE BEEN EXHIBITING A SUDDEN DEPLETION OF THE BATTERY. THE MAGNET RATE, WHICH IS A MEASURE OF THE BATTERY DEPLETION LEVEL, WAS MEASURED AT 90 PPM IN JANUARY OF 1995, AND 85 PPM IN NOVEMBER OF 1996.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROTHIN P-II BIPOLAR PULSE GENERATOR Implant | BIPOLAR IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS | 0623 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other | THE DEVICE 4230/002500 WAS IMPLANTED 06-MAY-1981 |