FDA Adverse Event
Malfunction
Summary report: N
REVEAL LINQ
MDR report key: 6163511
·
Received December 9, 2016
Report
- Report Number
- 9614453-2016-07360
- Event Type
- Malfunction
- Date Received
- December 9, 2016
- Date of Event
- September 23, 2016
- Report Date
- May 17, 2018
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DSI
- PMA / PMN Number
- K132649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 PATIENT'S IMPLANTABLE CARDIAC MONITOR (ICM) HAD UNDERSENSING AND T-WAVE OVERSENSING (TWOS) CAUSING FALSE EPISODES. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY IMPLANTABLE CARDIAC MONITOR CLINICAL STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 812444 | REVEAL LINQ | DETECTOR AND ALARM, ARRHYTHMIA | DSI | IPG MFG SWITZERLAND | LNQ11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |