FDA Adverse Event
Malfunction
Summary report: N
CONFIRM
MDR report key: 3920661
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14278
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- May 9, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- MXC
- PMA / PMN Number
- K081365
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR WENT INTO BACKUP OPERATION POST IMPLANT, AFTER SUSPECTED ELECTROCAUTERY INTERACTION. ON (B)(6) 2014 AFTER A SOFTWARE DOWNLOAD, NORMAL DEVICE FUNCTION RESUMED. THE PATIENTS CONDITION WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397935 | CONFIRM | IMPLANTABLE CARDIAC MONITOR | MXC | ST. JUDE MEDICAL, INC., CRMD | DM2102 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |