FDA Adverse Event
Injury
Summary report: N
MICROTHIN P-II BIPOLAR PULSE GENERATOR
MDR report key: 73610
·
Received January 16, 1997
Report
- Report Number
- 2124215-1997-00400
- Event Type
- Injury
- Date Received
- January 16, 1997
- Date of Event
- September 24, 1996
- Report Date
- October 10, 1996
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD WERE EXPLANTED DUE TO A SYNCOPAL EPISODE THAT RESULTED IN A LOSS OF CONSCIOUSNESS TO THE PATIENT. CPI MINIMUM LONGEVITY OF THE IPG 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. THIS DEVICE WAS IMPLANTED FOR 157 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 | 75 YR | Required Intervention |