FDA Adverse Event
Malfunction
Summary report: N
REVEAL LINQ
MDR report key: 4161769
·
Received October 10, 2014
Report
- Report Number
- 9614453-2014-02238
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- September 27, 2013
- Report Date
- July 22, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DSI
- PMA / PMN Number
- K132649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, IT WAS NOTED THAT THE DEVICE WAS PROGRAMMED TO STORE ATRIAL FIBRILLATION (AF) EPISODES WITH A DURATION OF GREATER THAN TEN MINUTES. THIS SETTING DIFFERS FROM THE DEFAULT SETTING. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE REVEAL LINQ STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640737 | REVEAL LINQ | DETECTOR AND ALARM, ARRHYTHMIA | DSI | IPG MFG SWITZERLAND | LNQ11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00086 YR |