FDA Adverse Event
Malfunction
Summary report: N
WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR
MDR report key: 6996739
·
Received November 2, 2017
Report
- Report Number
- 2184149-2017-00039
- Event Type
- Malfunction
- Date Received
- November 2, 2017
- Date of Event
- September 26, 2017
- Report Date
- December 14, 2017
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- JOQ
- PMA / PMN Number
- K092913
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
WHEN PACING COULD NOT BE PERFORMED, A LOOP RECORDER WAS IMPLANTED INSTEAD.
Description of Event or Problem · 1
DURING A PROCEDURE, THE EP-4 WOULD NOT COMMUNICATE WITH THE COMPUTER OR THE TOUCHSCREEN. WHEN PACING COULD NOT BE PERFORMED, A LOOP RECORDER WAS IMPLANTED. THE PROCEDURE WAS CANCELLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 775830 | WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR | EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR | JOQ | ST. JUDE MEDICAL, INC. | H403023 | 5355536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |