FDA Adverse Event
Death
Summary report: N
MEDTRONIC
MDR report key: 36521
·
Received August 27, 1996
Report
- Report Number
- 36521
- Event Type
- Death
- Date Received
- August 27, 1996
- Date of Event
- August 22, 1996
- Report Date
- August 23, 1996
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PACER WAS NOT SENSING CORRECTLY. WOULD NOT PACE THE VENTRICLE AT THE RATE THAT WAS DIALED IN. ANOTHER PACER WAS USED. PT EXPIRED. DEATH NOT ATTRIBUTED TO PACER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC Implant | PACER | DXY | MEDTRONIC, INC. | 5330 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Death| R |