FDA Adverse Event
Malfunction
Summary report: N
AF MONITOR PACKAGE STERI
MDR report key: 1223794
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03478
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- September 26, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- MXC
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE WEEK POST IMPLANT, THE LOOP RECORDER EXHIBITED MULTIPLE UNRECOVERABLE SOFTWARE ERRORS. THERE WERE DIFFICULTIES INTERROGATING THE DEVICE, MAINTAINING THE SESSION, AND PRINTING FROM THE WRAP-UP MENU. IT WAS NOTED THAT THE PATIENT USED THE PATIENT RECORDER TO CREATE AN EPISODE, BUT THE RECORDER DID NOT REPORT AN EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AF MONITOR PACKAGE STERI | IMPLANTABLE LOOP MONITOR | MXC | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | DM2100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |