FDA Adverse Event
Malfunction
Summary report: N
REVEAL LINQ
MDR report key: 3994074
·
Received August 8, 2014
Report
- Report Number
- 9614453-2014-01850
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 16, 2014
- Report Date
- May 16, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DSI
- PMA / PMN Number
- K132649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE REMOTE TRANSMISSION FOR THE PATIENT¿S IMPLANTABLE CARDIAC MONITOR (ICM) DEVICE NOTED COUNTS FOR PAUSE EPISODES, BUT THERE WERE NO PAUSE EPISODES IN THE EPISODE LIST. THE CLINICIAN EXPRESSED GREAT DISSATISFACTION IN HOW THIS DATA PRESENTED AND HAD SOME IMPROVEMENT SUGGESTIONS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469608 | REVEAL LINQ | DETECTOR AND ALARM, ARRHYTHMIA | DSI | IPG MFG SWITZERLAND | LNQ11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR |