FDA Adverse Event
Malfunction
Summary report: N
REVEAL LINQ
MDR report key: 3992894
·
Received August 8, 2014
Report
- Report Number
- 9614453-2014-01945
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 5, 2014
- Report Date
- June 24, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- DSI
- PMA / PMN Number
- K132649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
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 ONE DAY AFTER IMPLANT OF THE IMPLANTABLE CARDIAC MONITOR, FALSE ASYSTOLE EPISODES WERE OBSERVED ON THE ELECTROGRAM BECAUSE OF UNDERSENSING DUE TO ELECTRODE DISCONNECT. THE DEVICE IS STILL 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 |
|---|---|---|---|---|---|---|---|
| 468038 | REVEAL LINQ | DETECTOR AND ALARM, ARRHYTHMIA | DSI | IPG MFG SWITZERLAND | LNQ11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00088 YR |