FDA Adverse Event
Malfunction
Summary report: N
REVEAL LINQ
MDR report key: 8905860
·
Received August 19, 2019
Report
- Report Number
- 3008973940-2019-02295
- Event Type
- Malfunction
- Date Received
- August 19, 2019
- Date of Event
- August 2, 2019
- Report Date
- August 19, 2019
- Manufacturer
- MEDTRONIC SINGAPORE OPERATIONS
- Product Code
- DSI
- PMA / PMN Number
- K132649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXPERIENCED FALSE ASYSTOLE EPISODES DUE TO DIMINISHING R-WAVES. THE ICM 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 |
|---|---|---|---|---|---|---|---|
| 700595 | REVEAL LINQ | DETECTOR AND ALARM, ARRHYTHMIA | DSI | MEDTRONIC SINGAPORE OPERATIONS | LNQ11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |