FDA Adverse Event
Malfunction
Summary report: N
JOT DX ICM
MDR report key: 12669284
·
Received October 20, 2021
Report
- Report Number
- 2017865-2021-34269
- Event Type
- Malfunction
- Date Received
- October 20, 2021
- Date of Event
- October 1, 2021
- Report Date
- October 20, 2021
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- MXC
- UDI-DI
- 05415067040046
- PMA / PMN Number
- K163407
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY FOR A PAUSE EPISODE VIA A MERLIN.NET DEVICE TRANSMISSION. IT WAS DISCOVERED THAT THE EPISODE WAS FALSELY TRIGGERED DUE TO INTERMITTENT R-WAVE UNDER-SENSING, POSSIBLY DUE TO PATIENT POSITIONAL CHANGES. NO INTERVENTION TOOK PLACE AT THE TIME AND THE PATIENT WOULD CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1561038 | JOT DX ICM | IMPLANTABLE CARDIAC MONITOR | MXC | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | DM4500 | S000083011 | 05415067040046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |