FDA Adverse Event
Malfunction
Summary report: N
CONFIRM
MDR report key: 8259671
·
Received January 17, 2019
Report
- Report Number
- 2017865-2019-00860
- Event Type
- Malfunction
- Date Received
- January 17, 2019
- Date of Event
- January 3, 2019
- Report Date
- May 13, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- MXC
- UDI-DI
- 05415067027320
- PMA / PMN Number
- K163407
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR EXHIBITED UNDERSENSING. THE PATIENT PRESENTED IN CLINIC ON (B)(6) 2019. NO CHANGES WERE MADE. THE PATIENT WAS IN A STABLE CONDITION.
Description of Event or Problem · 1
NEW INFORMATION STATES THAT AN ASYMPTOMATIC PATIENT PRESENTED VIA REMOTE TRANSMISSION. UPON REVIEW, THE DEVICE EXHIBITED FALSE PAUSE EPISODE CAUSE BY R WAVES FALLING BELOW MAX SENSITIVITY POSSIBLY DUE TO POSITIONAL CHANGE. NO CHANGES WERE MADE. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52147 | CONFIRM | IMPLANTABLE CARDIAC MONITOR | MXC | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | DM3500 | S000055529 | 05415067027320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |