FDA Adverse Event
Injury
Summary report: N
MICROTHIN P-II UNIPOLAR PULSE GENERATOR
MDR report key: 94114
·
Received March 6, 1997
Report
- Report Number
- 2124215-1997-00946
- Event Type
- Injury
- Date Received
- March 6, 1997
- Date of Event
- December 23, 1996
- Report Date
- December 5, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED FOR 'BATTERY 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROTHIN P-II UNIPOLAR PULSE GENERATOR Implant | UNIPOLAR IMPLANTABLE PULSE GENERATOR | DXY | CARDIAC PACEMAKERS | 0523 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention | THE DEVICE 4150/010297 WAS IMPLANTED 28-MAR-1985 |