FDA Adverse Event
Injury
Summary report: N
MICROTHIN P-II BIPOLAR PULSE GENERATOR
MDR report key: 73788
·
Received January 16, 1997
Report
- Report Number
- 2124215-1997-00582
- Event Type
- Injury
- Date Received
- January 16, 1997
- Date of Event
- July 10, 1996
- Report Date
- November 7, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, IN
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED DUE TO BATTERY DEPLETION, AND PACEMAKER FAILURE. CPI MINIMUM LONGEVITY AT NOMINAL SETTINGS WITH A 500 OHM LEAD IS 77 MONTHS. CPI DOES NOT KNOW THE IMPLANT PARAMETERS OR THE LEAD RESISTANCE THROUGHOUT THE IMPLANT LIFE OF THE SYSTEM. THE IPG WAS IMPLANTED FOR 134 MONTHS.
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 | 62 YR | Required Intervention | THE DEVICE 4261/241651 WAS IMPLANTED 11-JUL-1996| THE DEVICE 4230/007763 WAS IMPLANTED 25-MAY-1985| THE DEVICE 0444/705973 WAS IMPLANTED 11-JUL-1996 |