FDA Adverse Event
Malfunction
Summary report: N
MICROPACE
MDR report key: 20452455
·
Received October 11, 2024
Report
- Report Number
- MW5161022
- Event Type
- Malfunction
- Date Received
- October 11, 2024
- Date of Event
- September 23, 2024
- Report Date
- October 8, 2024
- Manufacturer
- MICROPACE PTY. LTD.
- Product Code
- JOQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THIS WAS A CABLE THAT STOPPED WORKING. NOT SURE IF IT SHORTED OUT OR BROKE SOMEHOW. IT'S THE CARTO MAPPING SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1353117 | MICROPACE | GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE (FOR ELECTROPHYSIOLOGICAL STU | JOQ | MICROPACE PTY. LTD. | MICROPACE EPS320 | 17-064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male |