FDA Adverse Event
Malfunction
Summary report: N
CONFIRM
MDR report key: 4189433
·
Received January 11, 2014
Report
- Report Number
- 2017865-2014-02308
- Event Type
- Malfunction
- Date Received
- January 11, 2014
- Date of Event
- July 2, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC, CRMD
- Product Code
- MXC
- PMA / PMN Number
- K081365
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER BEING EXPOSED TO CAUTERY DURING IMPLANT THE DEVICE PRESENTED IN BACK UP MODE, AND DISPLAYED THE ERROR MESSAGE SAYING "FSM STATE ACTION ERROR HAS OCCURRED." A SOFTWARE DOWNLOAD RESOLVED THE ISSUE AND THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21390 | CONFIRM | IMPLANTABLE CARDIAC MONITOR, MXC | MXC | ST. JUDE MEDICAL, INC, CRMD | DM2100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |